wpengine

1470 POSTS 0 COMMENTS
This is the "wpengine" admin user that our staff uses to gain access to your admin area to provide support and troubleshooting. It can only be accessed by a button in our secure log that auto generates a password and dumps that password after the staff member has logged in. We have taken extreme measures to ensure that our own user is not going to be misused to harm any of our clients sites.

EFFORTLESS long-term study confirms safety and efficacy of Boston Scientific Subcutaneous...

Data collected from the EFFORTLESS study were presented as a late-breaking clinical trial at the 37th Annual Scientific Sessions of the Heart Rhythm Society (HRS) in San Francisco, USA.

Acutus Medical granted CE mark for AcQMap 3D

Acutus Medical has received CE mark approval for its AcQMap high resolution imaging and mapping system, and for its AcQMap catheter.

Cell Therapy grants Japan license to Daiichi Sankyo for Heartcel

Cell Therapy has granted the Japan license for its innovative cardiac regeneration medicine, Heartcel (immuno-modulatory progenitor (iMP) cells) to Daiichi Sankyo.

Large transvenous lead extraction study finds 95.7% of individual leads successfully...

The research was presented the Heart Rhythm Society's 37th Annual Scientific Sessions, and includes data from both high volume and low volume medical centres.

Studies support feasibility of extravascular implantable cardioverter defibrillation therapy

Several studies evaluating a novel approach to implantable cardioverter defibrillator (ICD) have shown the feasibility of therapy using Medtronic's EV-ICD system, according to a company release.

New data support safety and performance of Medtronic Micra system

Medtronic has announced clinical results highlighting the safety and performance profile of the miniaturised Micra transcatheter pacing system (TPS) at the 2016 Heart Rhythm Society meeting.

Routine ganglionic plexus ablation “should not be performed” in advanced atrial...

Results from the AFACT trial have shown no clinical benefits and significantly more complications associated with routine ganglionic plexus ablation for advanced atrial fibrillation patients. Data were presented at the 37th Heart Rhythm Society Scientific Sessions (HRS; 4-7 May, San Francisco, USA).

St Jude Medical MultiPoint Pacing Technology could achieve 87% patient response...

Results of St Jude Medical's MultiPoint Pacing investigational device exemption clinical study have been presented during a late-breaking clinical trial session at the Heart Rhythm Society's (HRS) 37th annual scientific sessions.

Stereotaxis to highlight new clinical results at HRS 2016

Stereotaxis will share results of recently published clinical studies, new technology enhancements and simulations of its computer-controlled mapping and lesion formation capabilities at HRS 2016.

FDA approves Boston Scientific navigation-enabled IntellaNav catheters

Boston Scientific has received US Food and Drug Administration (FDA) approval for two catheters that can be used with the company's Rhythmia mapping system.

George Van Hare

George Van Hare (The Louis Larrick Ward professor of Pediatrics and director, Division of Pediatric Cardiology, Washington University School of Medicine, St Louis, USA), has worked towards advancing paediatric electrophysiology, as a recognised specialty, in the paediatric cardiology world and the electrophysiology world. He considers that working as a paediatric electrophysiologist is a "rewarding" experience, because it has allowed him to diagnose and cure at a very early stage. He talks to C

Merit Medical launches interventional cardiac resynchronisation therapy initiative

Merit Medical Systems has officially launch its Interventional cardiac resynchronisation therapy initiative during the Heart Rhythm Society (HRS) Meeting in San Francisco, USA.

FDA approves Iperia MR conditional cardiac resynchronisation defibrillators

The Iperia ProMRI HF-T cardiac resynchronisation defibrillator has been approved by the US Food and Drug Administration (FDA).

Boston Scientific announces Heart Rhythm Society 2016 presentations

Boston Scientific has announced key data, including one late-breaking clinical trial, that will be featured at the 37th Annual Scientific Sessions of the Heart Rhythm Society (HRS) in San Francisco on May 4-7 2016.

US FDA grants Medtronic approval for Visia single-chamber implantable cardioverter defibrillators

Medtronic has announced it has received US Food and Drug Administration (FDA) approval for the Visia AF MRI SureScan and Visia AF single-chamber implantable cardioverter defibrillators (ICDs).

Seventy-fifth patient enrolled in GENETIC-AF bucindolol trial

The 75th patient has been enrolled in GENETIC-AF, a phase 2B/3 clinical trial evaluating bucindolol (Gencaro, Arca Biopharma) as a potential treatment for atrial fibrillation.

Boston Scientific receives CE mark for MRI labelling of Emblem S-ICD...

Boston Scientific has received CE mark approval for the new Emblem MRI subcutaneous implantable defibrillator (S-ICD) system, as well as magnetic resonance (MR) conditional labelling for all previously implanted Emblem S-ICD systems.

Empagliflozin (Jardiance) to be studied for the treatment of people with...

Boehringer Ingelheim and Eli Lilly are to conduct two outcome trials investigating the diabetes medicine empagliflozin (Jardiance) for the treatment of people with chronic heart failure.

Medtronic’s Reveal LINQ detects atrial fibrillation at higher rate than previously...

Medtronic has announced one-year results from a real-world study of patients who had a cryptogenic stroke, or stroke of unknown cause.

St Jude Medical announces EnSite Precision cardiac mapping system limited market...

St Jude Medical has announced expansion of its EnSite Precision cardiac mapping system limited market release in Europe and use of the new platform in more than 600 cases in nine countries since receiving CE mark in January 2016.

AtriCure receives FDA clearance for its cryoFORM cryoablation probe

AtriCure has received US Food and Drug Administration 510(k) clearance for the cryoFORM cryoablation probe, which is designed to offer increased probe flexibility to adapt to a variety of surgical cardiac ablation procedures.

Biotronik gets FDA approval for its BioMonitor 2 insertable cardiac monitor

Biotronik has announced Food and Drug Administration (FDA) approval of BioMonitor 2, an insertable cardiac remote monitor with ProMRI technology.

Healthcare workers’ radiation exposure tied to range of health problems

Healthcare professionals performing x-ray guided cardiovascular procedures may be at higher risk for health problems including orthopaedic problems, cataracts, skin lesions and cancers, according to new research.

INOVATE-HF data show no evidence that vagus nerve stimulation reduces death...

Results from the INOVATE-HF trial indicate that vagus nerve stimulation does not reduce the rate of death or heart failure events in chronic heart failure patients. The data were simultaneously presented at ACC 2016 and published in the Journal of the American College of Cardiology.

First leadless pacemaker approved in the USA

Medtronic has announced it has received US Food and Drug Administration (FDA) approval for its Micra Transcatheter Pacing System (TPS). The leadless device, which is 93% smaller than conventional pacemakers, provides a safe alternative for pacing without the complications associated with cardiac leads.

Development and commercialisation of andexanet alfa in Japan fully supported by...

Portola Pharmaceuticals has announced that it has entered into a clinical collaboration agreement with Daiichi Sankyo to develop andexanet alfa as an antidote for edoxaban, Daiichi Sankyo's Factor Xa inhibitor, in Japan.

American College of Cardiology elects A Allen Seals as chair of...

A Allen Seals has been elected chair of the American College of Cardiology (ACC) Board of Governors and secretary of the Board of Trustees, the main governing body of the ACC, for 2016-2017.

Richard Chazal assumes American College of Cardiology presidency

Richard Chazal has assumed his role as president of the American College of Cardiology (ACC) during the Convocation Ceremony held in conjunction with the ACC's 65th Annual Scientific Session in Chicago.

HeartLight System gets FDA approval for atrial fibrillation treatment

CardioFocus has announced that it has received premarket approval from the US Food and Drug Administration (FDA) for its HeartLight Endoscopic Ablation System for the treatment of patients with paroxysmal atrial fibrillation.

New independent data confirms benefits of CardioMEMS HF System

Northwell Health physicians presented data at the American College of Cardiology 65th Annual Scientific Session (2-4 April, Chicago, USA) showing heart failure management with the CardioMEMS HF System leads to significant improvements in quality of life and exercise capacity for patients with heart failure.

Two studies report on missed opportunities to avoid painful shocks at...

Many patients who have an implantable cardioverter defibrillator (ICD) are unaware that the device can be deactivated to prevent painful shocks in their final days of life, according to two new studies.

Test to predict risk of sudden cardiac death being developed in...

A new test to identify patients at risk of sudden cardiac death is being developed by researchers at the University of Leicester and Leicester's Hopsitals following a £183,000 grant from national charity Heart Research UK.

4WARD Coalition launches website to empower patient/healthcare provider communication

The 4WARD Coalition has launched AFib4WARD.com, an online tool designed to help non-valvular atrial fibrillation patients and their healthcare providers engage in informed discussions and shared decision making.

Intravenous vernakalant superior to ibutilide in recent on-set AF patients

Researchers in Austria have found shorter time to sinus rhythm in patients with recent-onset atrial fibrillation (AF) treated with intravenous vernakalant (Brinavess, Cardiome Pharma) compared with ibutilide treatment.

Stereotaxis completes patient enrolment for Niobe system’s post-market surveillance in Japan

Stereotaxis has announced that Takatsuki General Hospital in Japan has reached the milestone of treating 120 patients using the company's Niobe remote magnetic navigation system. This milestone completes the required patient enrolment for the Niobe system's post-market surveillance in Japan.

Presence of a wide and large S-wave in lead I is...

New research published in the Journal of the American College of Cardiology indicates that a wide/and or large S-wave in lead I is a powerful predictor of life-threatening ventricular arrhythmias in Brugada Syndrome patients with no history of cardiac arrest at presentation.

CE mark approval granted for new St Jude Medical Quartet quadripolar...

St Jude Medical has announced the launch and CE mark approval for three new Quartet left ventricular (LV) leads.

Zoll receives approval to market Thermogard XP in Japan

Zoll Medical has announced that its Japanese subsidiary, Asahi Kasei Zoll Medical, has obtained approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) to market the company's Thermogard XP.

AHA releases advisory proposing wearable defibrillators as potential treatment option

A wearable automatic defibrillator may be an option for patients who are at risk for life-threatening heart rhythm abnormalities but are not good candidates for an implantable cardiac defibrillator, according to an advisory for the American Heart Association (AHA).

Atrial fibrillation patients at highest stroke risk not prescribed necessary medication

Nearly half of all atrial fibrillation patients at the highest risk for stroke are not being prescribed blood thinners by their cardiologists, according to a new study.

Sir Nilesh Samani appointed as next British Heart Foundation medical director

Sir Nilesh Samani has been announced as the next medical director of the British Heart Foundation. He will succeed Peter Weissberg who will retire in October 2016.

FDA proposes ban on most powdered medical gloves

The US Food and Drug Administration has announced a proposal to ban most powdered gloves in the USA. While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury, according to an FDA news release.

AliveCor introduces Kardia Band electrocardiogram for Apple Watch

AliveCor has introduced the first medical-grade Electrocardiogram (EKG) band for the Apple Watch, the Kardia Band, along with a new app for smartphones.

FDA grants 510(k) clearance for InfoBionic MoMe Kardia

InfoBionic has received 510(k) clearance from the US Food and Drug Administration (FDA) for MoMe Kardia, a wireless, remote monitoring system.

Arca Biopharma announces update on GENETIC-AF trial

Arca Biopharma has announced the GENETIC-AF trial, which will evaluate bucindolol (Gencaro) as a potential treatment for atrial fibrillation.

NICE publishes final recommendation for sacubitril/valsartan

The UK National Institute for Health and Care Excellence (NICE) has recommended sacubitril/valsartan (Entresto) in its final draft guidance for use within the UK National Health Service.

Fluoroscopy times and radiation dose reduced in atrial fibrillation ablation with...

A real-world study has found that the SmartTouch (Biosense Webster) contact force-sensing catheter coupled with an Advanced Catheter Location feature during atrial fibrillation (AF) ablation reduced fluoroscopy times by 77%, radiation dose by 71% and procedural time by 19%.

New bidirectional mechanical lead extraction device is safe and efficient with...

A new bidirectional rotational mechanical lead extraction sheath is both safe and effective in performing lead extraction, according to a study published online ahead-of-print in Europace. Clinical success for the leads extracted using this novel sheath was 98.1% with no mortality or major complications.

Boston Scientific receives FDA approval for Blazer open-irrigated catheter

The approval of the Blazer OI catheter marks the first time Boston Scientific will offer an open-irrigated catheter to the US market.

BioMonitor 2 released in the UK and Ireland

BioMonitor 2 (Biotronik) is now available for patients in the UK and Ireland. The insertable device is designed to allow accurate and reliable continuous detection of cardiac electrical events.

Zoll announces several management changes

LifeVest 4000 Zoll
Zoll Medical has announced a new chief executive officer and senior vice president of resuscitation as Richard A Packer is to lead Asahi Kasei's Healthcare Business Unit.

St Jude Medical granted CE mark approval for MRI compatible labelling...

CE mark approval has been secured for the magnetic resonance (MR) conditional labelling for 1.5T scans for the Nanostim leadless pacemaker from St Jude Medical.

First implantations of EBR Systems’ WiSE technology take place

The first commercial implantations of WiSE (wireless stimulation endocardially) technology (EBR Systems) have taken place in the UK and Czech Republic.

Hypertrophic cardiomyopathy patients at risk of sudden cardiac death may be...

Patients with hypertrophic cardiomyopathy at risk of sudden cardiac death and without pacing indication may be eligible for Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) implantation, according to results of a single-centre study.

APN Health granted FDA clearance for Navid 3D cardiac mapping system

The system produces real-time 3D catheter location information from 2D fluoroscopic images of the heart, and correlates them with the electrical activation of the heart.

Biotronik opens training facility and innovation centre in New York City,...

Biotronik has opened the Education and Innovation Center in New York, USA to hold educational programmes.

Boston Scientific receives FDA approval for Acuity X4 quadripolar leads

The US Food and Drug Administration has granted approval to Boston Scientific for its Acuity X4 quadripolar left ventricular leads. The company can now offer its first full X4 cardiac resynchronisation system to the US market.

Medtronic receives CE mark for three MRI-compatible cardiac resynchronisation therapy defibrillators

The three cardiac resynchronisation therapy defibrillators (CRT-Ds) are approved for 3 Tesla magnetic resonance imaging scans. These devices are the first and only CRT-Ds approved for this level of MRI, according to a company release.

American College of Cardiology releases competency guidelines for general cardiologists

The American College of Cardiology has release its 2016 ACC Lifelong Learning Competencies for General Cardiologists. This document defines the knowledge, skills and behaviours expected of practising clinical cardiologists.

American Heart Association warns that African Americans and Hispanics face greater...

Studies have shown that heart failure affects African American individuals with roughly twice the incidence of that of Caucasians. The Hispanic population has the second-highest risk of developing heart failure in the USA.

FDA panel offers guidance on leadless pacing technology

The panel provided insight around patient selection and post approval study methodology, folowing a panel discussion on leadless pacing technology.

FDA Panel provides recommendations on adverse events, long-term safety and postmarket...

The FDA's Circulatory System Devices Panel of the Medical Devices Advisory has made recommendations for leadless pacemakers regarding adverse events, long-term safety issues (including battery longevity), necessary elements for postmarket surveillance, indications for use and labelling, and implanting physicians' training.

St Jude Medical receives FDA approval for MultiPoint pacing technology

This technology is designed to provide additional options which may benefit cardiac resynchronisation therapy patients who are not responsive to other methods of pacing.

First patient enrolled in AtriCure postoperative atrial fibrillation study

The first patient has been enrolled in the ATLAS (AtriClip Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures) clinical study.

Idarucizumab reimbursement granted in England, Ireland and Wales

The agreement of the English National Institute for Health and Care Excellence, the All Wales Medicines Strategy Group and the Irish National Centre for Pharmoeconomics has granted the drug eligibility for full reimbursement, without the need for a full appraisal in these countries.

Left atrial appendage isolation with cryoballoon may work as an adjunctive...

Researchers in Turkey have found that additional left atrial appendage (LAA) isolation using second generation cryoballoon technology is feasible and safe and that it may be considered as an adjunctive therapy to pulmonary vein isolation for persistent atrial fibrillation (AF) treatment.

Regenerate Life Science formed to develop advancement of cardiovascular medicine with...

The company will concentrate on developing new technologies to aid in the advancement of cardiovascular medicines using stem cell therapy.

Robotically-guided approach offers alternative LV lead implantation through the coronary sinus

Left ventricular (LV) lead implantation for cardiac resynchronisation therapy (CRT) with a robotically-guided surgical approach through the coronary sinus seems to offer a new alternative when conventional approaches are not suitable, a new study has found.

Biotronik Itrevia 7 HF-T resynchronisation therapy defibrillator approved in Japan for...

The Japanese launch of the device took place in July 2015. This is the first and only CRT-D in Japan with such conditions, according to a company release. All already implanted devices have been deemed safe for full-body MRI scans at 1.5 tesla strength.

FDA announces Advisory Committee meeting on leadless pacing

Members of the FDA's Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet on 18 February 2016 to provide advice and recommendations on leadless cardiac pacemaker device technology.

Spectranetics Bridge occlusion balloon cleared by the US Food and Drug...

The company has received premarket notification 510(k) clearance for the Bridge Occlusion Balloon for lead extraction procedures. This clearance will initiate a controlled market release, according to a Spectranetics release, with full market launch at the Heart Rhythm Society's 37th Annual Scientific Sessions.

Implantation of multiple leadless pacemakers is feasible without impacting cardiac function

An animal study from China has indicated that it is feasible to implant two leadless pacemakers in the right ventricle of the same heart without impacting cardiac function at six months.

New drug candidate may prevent and reverse hypertrophic cardiomyopathy in mouse...

MYK-461, a drug candidate from MyoKardia, may prevent and reverse development of hypertrophic cardiomyopathy in multiple genetic mouse models, according to a study published in Science.

Medtronic first to receive FDA approval for MR-conditional CRT-Ds

Medtronic has announced that it is the first company to receive US Food and Drug Administration approval for magnetic resonance imaging (MRI) conditional cardiac resynchronisation therapy (CRT) defibrillators for the treatment of heart failure.

Cardiologists expose concerns regarding battery life of cardiac implantable electronic devices

The battery life of cardiac implantable electronic devices must be improved to reduce the need for replacement and the risks this carries for patients, argue UK cardiologists John Dean and Neil Sulke in an editorial published in BMJ.

Abbott acquires Kalila Medical

Kalila Medical has a novel steerable sheath that is designed to help physicians more easily access and perform catheter-based electrophysiology procedures.

Portola license Japanese commercial rights for andexanet alfa to Bristol-Myers Squibb...

Portola has also entered into a clinical collaboration agreement with Bayer HealthCare to include its Factor Xa inhibitor rivaroxaban in this clinical development programme in Japan.

Biotronik receives CE mark for new Ilivia implantable cardioverter defibrillators and...

Ilivia devices come with the company's ProMRI technology, as well as MRI AutoDetect, which is designed to allow the cardiologist to activate a window in which all device functionality is maintained until a patient actually undergoes an MRI scan.

Arca enrols 50th patient in GENETIC-AF atrial fibrillation prevention trial

This trial evaluates bucindolol hydrochloride (Gencaro) as a potential genetically-targeted treatment for the prevention of atrial fibrillation.

Stereotaxis and Philips extend development collaboration for Niobe ES and Allura...

Stereotaxis and Philips have signed an addendum, pursuant to their existing development and cooperation agreement, to facilitate development of a new interface between each company's most advanced systems for electrophysiology and interventional cardiology procedures.

Optisure high voltage leads classified as Class 1 Advisory by US...

A previously communicated voluntary global field safety action related to St Jude Medical's Optisure Dual Coil Defibrillation Leads has now been classified as a Class 1 Advisory by the US Food and Drug Administration.

German public health body grant once-daily edoxaban indication for prevention of...

The German Federal Joint Committee (Gemeinsamer Bundesausschuss-G-BA) has granted Daiichi Sankyo's edoxaban (Lixiana) an indication of a minor additional benefit.

AtriCure receives approval for AtriClip products from Japanese Ministry of Health,...

AtriCure has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its AtriClip products, which will be distributed in Japan by Century Medical.

Sacubitril/valsartan now available in the UK for the treatment of HFrEF...

Sacubitril/valsartan (Entresto, Novartis) has been made available in the UK for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction.

Imricor Medical Systems’ Advantage-MR EP recorder and stimulator system granted CE...

The Advantage-MR EP recorder/stimulator system is a magnetic resonance conditional recording system for magnetic resonance imaging-guided electrophysiology procedures.

Women and men with heart failure benefit similarly from implantable cardioverter...

An analysis from the US Get with the guidelines for heart failure registry has found that women and men with heart failure and reduced left ventricular ejection fraction benefit similarly from implantable cardioverter defibrillators.

Jonathan Kalman

A leading heart rhythm expert in Australia, Jonathan M Kalman directs both clinical and research groups in the Department of Cardiac Arrhythmias at the Royal Melbourne Hospital and University of Melbourne, Australia. In this interview, he recalls details of the first curative ablation procedure for atrial fibrillation in Australia and talks about the impact of lifestyle modification in atrial fibrillation management.

Has leadless pacing changed practice?

Chu-Pak Lau explores the development and use of externally-powered and entirely intracardiac leadless pacemakers, and considers the effect they have had on clinical practice.

Verseon presents data on new class of anticoagulants at the 8th...

The recently-obtained data demonstrates continuing and steady progress for the drug candidates in Verseon's anticoagulation program, according to a press release.

AliveCor partners with LifeWatch to expand into remote patient monitoring

AliveCor are to partner with LifeWatch AG. AliveCor Mobile ECG will be integrated into LifeWatch's remote cardiac monitoring service. This represents AliveCor's first step into remote patient monitoring.

Stereotaxis begins multicentre, randomised superiority study on ventricular tachycardia ablation outcomes

Stereotaxis has initiated its first prospective, multicentre, randomised clinical study to compare radiofrequency ablation outcomes generated using its Niobe ES remote magnetic navigation system to manual approaches in ischaemic scar ventricular tachycardia (VT) patients.

In the absence of testing, ICD optimisation should always be done

Mark W Kroll (Minneapolis, USA) writes about the importance of optimisation of implantable cardioverter defibrillators (ICDs) in the absence of defibrillation threshold testing.

New ultrasound-based system shows promise mapping atrial fibrillation

Initial findings have shown that a new ultrasound-based imaging system with continuous dipole density mapping provides real-time rapid global left atrial reconstruction and compares favourably to segmented computed tomography (CT).

Using the American Heart Association’s seven measures for heart health may...

Scoring highly on the American Heart Association (AHA)'s Life's Simple 7 checklist has been associated with a reduction in heart failure risk, according to a study published Circulation: Heart Failure.

Biotronik Iperia ICD systems with ProMRI technology receive FDA approval

Biotronik has been granted US Food and Drug Administration approval for use of a group of implantable cardioverter defibrillator systems with magnetic resonance imaging scans.

Biologics License Application submission completed for andexanet alfa

Portola Pharmaceuticals have completed the submission of a Biologics License Application for its investigational agent andexanet alfa to the US Food and Drug Administration.

LifeWatch Services acquires INR monitoring company, FlexLife Health

LifeWatch Services has acquired FlexLife Health, a company which offers patients remote services to monitor and measure coagulation.

Zoll LiveVest wearable defibrillator receives FDA approval for paediatric use

LiveVest is now approved for use by certain children who are at risk for sudden cardiac arrest, but who are not candidates for an implantable defibrillator device

LuxCath technology demonstrates promising results during first-in-man cardiac ablation procedures

The LuxCath optical tissue interrogation technology was used in eleven patients suffering from arrhythmias such as atrial flutter, AV nodal re-entrant tachycardia, and atrial fibrillation.

American Heart Association update shows that one in every three deaths...

This update-which has been produced since 1958-is made up from the most-recent data available compiled by the AHA, the National Institutes of Health, the Centers for Disease Control and Prevention and other government sources.

Advances in left atrial appendage occlusion and peri-procedural challenges

Dhiraj Gupta (Liverpool, UK) overviews developments in two left atrial appendage (LAA) occlusion devices, which have helped make the implant procedure safer, easier and quicker. He also highlights current challenges related to overall peri-procedural patient management.

First patient enrolled in international CEASE atrial fibrillation study

The first patient has been enrolled in the CEASE (combined endoscopic epicardial and percutaneous) atrial fibrillation (AF) clinical study, according to a press release from AtriCure.

New study evaluating whether pacemakers with closed loop stimulation prevent reflex...

BIOSync CLS will investigate the efficacy of the uniquely physiologic rate response sensor CLS in preventing syncope.

University of Washington to lead US expansion of Medtronic’s HeartRescue project

HeartRescue is a Medtronic Philanthropy partnership launched in five US states in 2010, which aims to improve Sudden Cardiac Arrest (SCA) survival rates.

Industry’s first WiFi-based remote cardiac rhythm monitor introduced by ScottCare Corporation

The device enables the clinician to access real-time streaming for live patient visibility, auto-detection of arrhythmia events, and wireless transmission of three channels of ECG data.

Bridge occlusion balloon submitted for FDA 510(k) Premarket Notification for lead...

The device from Spectranetics is designed to substantially reduce blood loss in the event of a superior vena cava tear.

Biotronik and cardiology experts join Heartbeat International for scientific symposium

Biotronik is to support its charity partner, Heartbeat International (HBI) at the 25th Interamerican Congress of Cardiology, in Santiago, Chile.

Patients with chronic kidney disease benefit from pacing left and right...

Cardiac resynchronisation therapy with defibrillator may prevent hospitalisation due to heart failure, when compared to treatment with implantable cardioverter defibrillator alone.

Insertable cardiac monitors may help decide safe discontinuation of oral anticoagulation...

A strategy including insertable cardiac monitors (ICM) to guide rhythm control with antiarrhythmic drugs and assessment of AF burden may allow safe discontinuation of oral anticoagulation in AF patients at high risk of bleeding.

Biotronik releases Eluna 8 pacemaker in Japan

The device is approved for use during 1.5 Tesla full-body MRI scans and ultra-high strength 3.0 Tesla MRI scans with an exclusion zone.

Leading heart failure doctors pledge united action to improve patient outcomes

Leading heart failure doctors from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC) have united in a pledge to improve patient outcomes and reduce the burden of heart failure on society.

St Jude Medical gets CE mark for MRI compatibility on Quadra...

The Quadra Assura cardiac resynchronisation therapy defibrillator (CRT-D) is now approved for use with magnetic resonance imaging (MRI) scanning systems at 1.5 Tesla.

B3 trial to evaluate benefits of unique rate response algorithm for...

This trial aims to determine if closed loop stimulation can delay the onset of atrial fibrillation and reduce the risk of stroke.

Medtronic recalls three models of pacemakers due to battery impedance

Medtronic has reported an issue with the long-term battery performance of its InSync III cardiac resynchronisation therapy-pacemakers (CRT-P) (models 8042, 8042B and 8042U). The Food and Drug Administration (FDA) has designated this issue as a Class II recall.

Idarucizumab licensed in Europe as specific reversal agent of dabigatran

Boehringer Ingelheim has announced that the European Commission has licensed idarucizumab (Praxbind) for rapid and specific reversal of the anticoagulant effects of dabigatran etexilate in cases of emergency surgery/urgent procedures or in situations of life-threatening or uncontrolled bleeding.

Adults with congenital heart defects at considerably higher risk of stroke

A study has shown heart failure, diabetes and recent heart attacks to be the strongest predictors of stroke caused by a blocked artery.

Four societies release collaborative expert consensus statement on ICD programming and...

These global recommendations are from The Heart Rhythm Society (HRS), European Heart Rhythm Association (EHRA), Asia Pacific Heart Rhythm Society (APHRS), and the Socieded Latinoamericana de Estimulacion Cardiaca y Electrofisiologia (SOLAECE).

Novartis’ Entresto receives European authorisation for chronic heart failure treatment

Novartis' Entresto (sacubitril/valsartan) has been authorised for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).

Portola Pharmaceuticals’ Phase 3 ANNEXATM study results published

The results were published online by The New England Journal of Medicine, while the ANNEXA-R data were presented during a late-breaking clinical trial session at AHA Scientific Sessions 2015.

Ebit receives 2015 Frost and Sullivan European Award for Technology Leadership

This award recognises Ebit's Suitestensa cardiovascular information system (CVIS) integration platform.

Biosense Webster acquires Coherex Medical

This acquisition adds the Coherex WaveCrest left atrial appendage (LAA) occlusion system to BioSense's portfolio.

Micra pacemaker from Medtronic wins 2015 ‘Best of What’s New’ award...

The Micra pacemaker was chosen from thousands of submissions, and is one of among 100 honourees that are seen represent a significant leap forward in their respective categories by the magazine.

Greater long-term success rates for Stereotaxis’ Niobe system compared to manual...

The results of an independent, multicentre study, which looked at the procedural benefits and outcomes of patients undergoing radio frequency ablation therapy for ventricular tachycardia, were published at the AHA.

Medtronic launch newly-FDA approved MyCareLink Smart app-based monitor

According to Medtronic, this is the world's first app-based remote monitoring system for patients with implantable pacemakers.

BioMonitor 2 cardiac remote monitor launched in Europe by Biotronik

The new device is a subcutaneous, insertable cardiac remote monitor designed to continuously monitor cardiac electrical events reliably and accurately.

New study has “major physiopathological and clinical implications” for the management...

Josep Brugada (Barcelona, Spain), Carlo Pappone (Milan, Italy) and others report in Circulation: Arrhythmia and Electrophysiology that ablation of abnormal epicardial substrate in patients with Brugada syndrome can eliminate the phenotype expression of the syndrome.

AliveCor appoints Vic Gundotra as new chief executive officer

Vic Gundotra has worked as a senior vice president at Google, after spending 15 years with Microsoft.

Micra TPS meets global clinical trial safety and effectiveness endpoints

The transcatheter pacing system from Medtronic is the smallest pacemaker on the market.

Partners of heart defibrillator patients more concerned about resuming sex

Concerns for both patients and their partners declined after three months.

Global symposium on Advanced Concepts in Electrophysiology receives support from Biotronik

The symposium is an educational program for electrophysiologists and device-oriented cardiologists.

Study shows increased risk of cardiac arrhythmias and cardiac death with...

The meta-analysis-which covered 33 studies involving more than 20 million patients-has been published in the Journal of the American College of Cardiology.

Debate on defibrillation testing continues

Speaking at a debate about the value of defibrillator threshold testing in patients with ICDs, Klaus Witte (Leeds, UK) told delegates at the Heart Rhythm Congress that such testing was a "pointless" intervention because it does not provide benefit and may be associated with adverse events. Nick Linker (Middlesbrough, UK), who argued against Witte, said that there is still a significant proportion of patients-who were not included in the major trials of defibrillation testing-for whom

LivaNova announces launch of the Platinum ICD & CRT-D range

Platinum is designed to protect patients from avoidable replacement surgeries and the inherent risk of complications.

New recommendations green-light some athletes with heart disease to compete in...

The recommendations from the American Heart Association and the American College of Cardiology may permit participation in competitive sports for some athletes with long QT syndrome

Psychological implications and management for patients with implantable cardioverter defibrillators

The implantation of an implantable cardioverter defibrillator (ICD) device poses numerous psychosocial challenges, which have been shown to significantly influence functional outcomes in this population. Therefore, the optimisation of medical therapy and provision of psychological support is key to managing the patient's biopsychosocial functioning, write Elizabeth Banwell, Katie Murray and Stephen Gunning.

Blackouts and near drownings may signal sudden death risk

Blackouts and near drownings may point to long QT syndrome (LQTS), signalling an increased risk of sudden death, according to research presented at the SA Heart Congress (25-28 October, Sun City, South Africa) by Paul Brink, Tygerberg, South Africa.

Medtronic receives CE mark for new single-chamber ICDs designed to detect...

The Visia AF and Visia AF MRI SureScan are designed to detect and monitor new onset, asymptomatic and previously undiagnosed atrial fibrillation.

Idarucizumab gets accelerated FDA approval for use in patients in need...

Idarucizumab (Praxbind) is the first reversal agent approved specifically for dabigatran and works by binding to the drug compound to neutralise its effect.

Pacemakers identify atrial fibrillation and enable initiation of stroke prevention

According to research presented at Acute Cardiovascular Care 2015, pacemaker checks are a good way to identify new cases of atrial fibrillation so that anticoagulation can be started to prevent strokes.

The American Heart Association and Heart Rhythm Society coordinate to improve...

The American Heart Association (AHA) and Heart Rhythm Society (HRS) have announced a collaboration designed to improve the quality of care of atrial fibrillation (AFib) patients and advance to cardiovascular research.

Michael Glikson

Michael Glikson (Tel Hashomer, Israel) has contributed to the development of technologies for CRT, modern lead extraction, advanced mapping ablation of AF and VT and LAA occlusion. Glikson's current projects as president of the Israel Heart Society and co-president of the International Dead Sea Symposium (IDSS) on Innovations in Cardiac Arrhythmias and Device Therapy reflect his innovative approach in the field. He speaks to Cardiac Rhythm News about these projects, other highlights in his

CardioKinetix announces South Korean approval for the Parachute System for heart...

Regulatory approval has been granted in South Korea for the Parachute System by CardioKinetix by the Korean Ministry of Food and Drug Safety (MFDS).

St Jude Medical completes acquisition of Thoratec

St Jude Medical has announced its completion of the previously announced acquisition of Thoratec Corporation, a global leader in mechanical circulatory support technology for the treatment of advanced heart failure.

St Jude Medical announces CE mark approval for the HeartMate 3...

St Jude Medical has announced that it has received CE mark approval for the HeartMate 3 Left Ventricular Assist System (LVAS). This is a cardiac support option for advanced heart failure patients awaiting transplantation who are not candidates for heart transplantation, or in myocardial recovery.

Role of rotors in mapping and ablation of ventricular fibrillation

In recently published studies, modulation of rotors by ablation seems to be effective in termination of atrial fibrillation. Now, researchers are exploring the role of rotors in ventricular fibrillation. Siva K Mulpuru (Mayo Clinic, Rochester, USA), discusses the latest research in this field.

AtriCure to acquire nContact

AtriCure has entered into a definitive merger agreement under which it will acquire nContact, a privately-held developer of innovative cardiac ablation solutions.

First wireless cardiac pacing system for heart failure receives the CE...

EBR Systems has announced the CE mark approval for its Wise (Wireless stimulation endocardially) technology, which is the world's only wireless endocardial pacing system for cardiac resynchronisation therapy (CRT).

AtriCure announces launch of the Cryoform cryoablation probe

Atricure has announced the launch of the Cryoform cryoablation probe, which offers increased probe flexibility to adapt to a variety of surgical ablation procedures.

Acutus Medical expands leadership team

John Dahldorf, Martin Chambers and Steven McQuillan join the company as chief financial officer, chief commercial officer and senior vice president, Regulatory and Clinical Affairs, respectively.

Benefits of autonomic regulation therapy for heart failure are maintained after...

Data show that autonomic regulation therapy in patients with moderate to severe chronic heart failure and impaired heart function is well tolerated, safe, improves the heart's ability to pump blood, and reduces the frequency and severity of symptoms associated with chronic heart failure.

Novel oral anticoagulants require improved safety data to challenge warfarin

More real-world safety data could potentially address the issue of under-dosing and under-treatment with novel oral anticoagulants (NOACs) in global practice, says an analyst with research and consulting firm GlobalData.

European Medicines Agency recommends dabigatran antidote after accelerated assessment

The European Medicines Agency (EMA) has recommended granting a marketing authorisation, following accelerated assessment, for idarucizumab (Praxbind) as a specific antidote to dabigatran etexilate (Pradaxa).

Entresto (sacubitril valsartan) recommended by CHMP for EU approval

Pending final approval by the European Commission, Entresto (sacubitril valsartan) will be licensed for use in the UK for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction.

NICE recommends once-daily Lixiana (edoxaban) for preventing stroke and systemic embolism...

The National Institute for Health and Care Excellence (NICE), the medicines cost-effectiveness body for England and Wales, has recommended a new treatment to help prevent stroke and systemic embolism in patients suffering from atrial fibrillation.

Societies release new guideline for treating supraventricular tachycardia

A new guideline aimed at helping clinicians treat patients with supraventricular tachycardia has been released by the American College of Cardiology, American Heart Association, and Heart Rhythm Society.

US societies release updated training requirements for clinical electrophysiology

Due to the complex nature of clinical cardiac electrophysiology, an updated training statement released by the American College of Cardiology, the American Heart Association and the Heart Rhythm Society, is calling for increased training for practitioners.

Laguna Pharmaceuticals initiates phase 3 study of vanoxerine in atrial fibrillation...

The study, known as RESTORE SR, will enrol 600 subjects at trial sites in the USA and other countries and will evaluate vanoxerine at a 400mg dose.

New data demonstrate sustained reversal of anticoagulant effect of Factor Xa...

The second part of Portola Pharmaceuticals' phase 3 ANNEXATM-R study achieved all primary and secondary endpoints with high statistical significance.

Physio-Control to acquire HeartSine

Financial details of the transaction are not being released. The combination creates one of the world's largest AED solutions providers.

CardioFocus’ HeartLight PMA for the treatment of atrial fibrillation filed and...

The accepted PMA application includes safety and effectiveness data from the company's multicentre HeartLight pivotal clinical trial, a randomised, controlled study in which a total of 353 patients were treated at 19 US centres.

First MRI-conditional implantable cardioverter defibrillator system receives FDA approval

Medtronic has announced that it has received the first US Food and Drug Administration (FDA) approval for an implantable cardioverter defibrillator (ICD) system for use with magnetic resonance imaging (MRI) scans.

First patient enrolled in study of Eliquis (apixaban) in NVAF patients...

This two-by-two factorial, randomised controlled trial will evaluate the safety of Eliquis versus warfarin or other vitamin K antagonists (VKA) in patients with NVAF and a recent acute coronary syndrome or undergoing PCI.

Simple test predicts obstructive sleep apnoea in patients hospitalised for heart...

Researchers at Thomas Jefferson University, Philadelphia, USA, have showed that a simple questionnaire, evaluation and pulse-oximetry monitoring can lead to early detection of sleep apnoea in patients hospitalised for congestive heart failure.

Electrical left atrial appendage isolation helps to improve freedom from long-standing...

A randomised, multicentre study has found improvement in the long-term freedom from long-standing persistent atrial fibrillation (AF) in patients who underwent an ablation plus empirical electrical left atrial appendage isolation strategy. No major complications were reported.

LCZ696 to be available to UK’s NHS under the Early Access...

LCZ696 (sacubitril valsartan) will be made available to eligible patients in the UK before a final European licensing decision is made.

New real-world study reveals low bleeding rates with rivaroxaban in atrial...

Results from the real-world study XANTUS have shown low rates of major bleeding in patients with atrial fibrillation taking rivaroxaban (Xarelto, Bayer Healthcare) for stroke prevention. Data were consistent with findings from the pivotal phase III clinical trial, ROCKET-AF.

Data from five US real-world trials comparing apixaban with other oral...

The studies compared the risk of different bleeding related outcomes, including major bleeding and/or any bleeding, hospitalisation and bleeding-related 30-day readmissions in routine clinical practice setting for apixaban versus warfarin, rivaroxaban and dabigatran.

ESC recommends subcutaneous defibrillators for management of ventricular arrhythmias and prevention...

The new guidelines now recommend that subcutaneous defibrillators (S-ICDs) should be considered as an alternative to transvenous defibrillators in patients with an indication for an ICD when pacing therapy is not needed.

Global registry presents two-year outcomes data in more than 17,000 newly-diagnosed...

These two-year prospective outcomes from cohorts 1 and 2 show a mortality rate of 3.83% per person year compared to stroke rates of 1.25% per person year and major bleeding rates of 0.7% per person year.

New studies identify gene associated with sudden cardiac death

First-of-its-kind findings from two independent studies have identified a gene associated with sudden cardiac death.

Secondhand smoke during pregnancy and early childhood linked to atrial fibrillation...

A first-of-its-kind study indicates that gestational and early life secondhand smoke exposure may double one's chance of developing atrial fibrillation as an adult.

Personal MedSystems introduces CardioSecur 22-lead mobile ECG at ESC Congress 2015

The next generation of electrocardiogram (ESC) solutions can be run with a smartphone or tablet PC, four electrodes and the CardioSecur App enabling the diagnosis and localisation of cardiac ischaemia, rhythm disorders and posterior wall infarctions.

LEADLESS II shows positive safety and efficacy outcomes with Nanostim

PREVAIL principal study investigator Vivek Reddy
Primary results from the LEADLESS II study have shown positive efficacy and safety outcomes with the Nanostim leadless pacemaker (St Jude Medical) for patients who require a single-chamber ventricular pacemaker.

Study highlights gender-related differences in athletes’ hearts

The study about gender differences in athletes' hearts highlights the importance of understanding how women's hearts work, and that what looks normal in men could reveal problems in women.

Sudden cardiac death in sport may occur in healthy hearts

Study reveals how physical exertion may trigger sudden death in people with apparently healthy hearts.

ESC and Boehringer Ingelheim launch new drive for innovation in cardiovascular...

The ESC Grants for Medical Research Innovation programme will see four grants of up to €400,000 each awarded to researchers or clinicians following live presentations by selected finalists to a panel of high profile experts appointed by the ESC.

Westmead Hospital provides data supporting ablation effectiveness of Stereotaxis magnetic navigation

Stereotaxis and Westmead Hospital in Australia have announced findings of a study comparing the stability of a Niobe remote magnetic navigation system catheter group and a manually controlled catheter group in a validated cardiac wall motion simulator.

BioControl Medical completes enrolment in the INOVATE-HF study of the CardioFit...

INOVATE-HF has enrolled a total of 725 patients at 86 centres in the USA and Europe, making it the largest prospective, randomised device study to evaluate the treatment of heart failure with vagus nerve stimulation.

Biotronik gets CE mark approval for last two generations of ProMRI...

Biotronik has announced CE mark approval for its last two generations of ProMRI cardiac resynchronisation therapy defibrillator (CRT-Ds) systems. The approval allows full-body MRI scanning.

Biotronik announces CE mark approval and pilot study results for BioMonitor...

Biotronik has announced CE mark approval and the results of a pilot study into the performance of the subcutaneous, insertable cardiac monitor BioMonitor 2.

Second generation cryoballoon shows favourable outcomes treating persistent atrial fibrillation

The largest study to date exploring the mid-term efficacy of cryoablation with the second generation device has shown favourable outcomes in patients with persistent atrial fibrillation. At a median follow-up of 10 months, 67% of patients were in sinus rhythm.

Boston Scientific announces CE mark for MRI compatible labelling for ICD...

This revised labelling ensures that future patients and those already implanted with these systems are able to undergo MRI scans if indicated.

E-health vital in battle against heart disease say European cardiology leaders

A European Society of Cardiology (ESC) position paper published in European Heart Journal outlines how the ESC will exploit e-health in education and research, while tackling issues of quality control and data security.

WomenHeart launches first virtual support network for women living with atrial...

The programme, which starts in September during Atrial Fibrillation Awareness Month, aims to reach women living with heart disease who do not otherwise have access to patient support services.

GARFIELD-AF Registry data to be featured at ESC Congress 2015

A satellite symposium and four GARFIELD-AF presentations will demonstrate how antithrombotic treatment patterns are evolving in the real-world and the impact on clinical outcomes in newly diagnosed atrial fibrillation patients.

Mobile technology may help people improve health behaviours

Smartphone applications and wearable sensors have the potential to help people make healthier lifestyle choices, but, according to the American Heart Association, scientific evidence of mobile health technologies' effectiveness for reducing risk factors for heart disease and stroke is limited.

Moderate physical activity associated with lower risk of heart failure in...

A new study shows that walking and cycling for 20 minutes per day has greatest impact on lowering the risk of heart failure.

Guideline-based algorithm helps to reduce syncope recurrence in old patients with...

A sequential algorithm, which includes carotid sinus massage, tilt testing and implantable loop recorder implantation, helps to reduce syncope recurrence to 9% at one year in old patients with severe recurrent syncopes, according to results from the Syncope unit project 2 (SUP 2) study.

Study highlights advantages of Stereotaxis platform in treating ventricular tachycardia

A seven-year study indicates the Stereotaxis remote magnetic navigation platform's success in ventricular tachycardia ablations compared to both contact force sensing and other manual catheters.

NICE recommends once-daily edoxaban for preventing stroke and systemic embolism in...

NICE Final Appraisal Determination recommends that edoxaban is a cost-effective use of NHS resources.

Biotronik enrols first patients in the BIO|GUARD-MI study

Study evaluates whether early detection of cardiac arrhythmias by BioMonitor with home monitoring reduces major cardiovascular events in post-acute myocardial infarction patients.

Addressing social factors critical for continued fight against heart disease and...

Deaths from heart attacks, strokes and other heart diseases have been declining, but social factors, including race, income, environment and education could reverse that trend.

Biotronik begins first study to assess relevance of defibrillator back-up after...

BioCONTINUE is the first study to investigate the relevance of defibrillator back-up following first device replacement in a heart failure patient population with a primary indication for a cardiac resynchronisation therapy defibrillator (CRT-D).

Boston Scientific to become significant shareholder in Preventice Solutions

Boston Scientific is also to become the exclusive global sales and marketing representative for the company's cardiology-related offerings.

Sensor-based electromagnetic tracking system helps to improve resynchronisation therapy implant procedures

A sensor-based electromagnetic tracking system helps to improve cardiac resynchronisation therapy (CRT) implantation facilitating speed of the procedure, reducing exposure to radiation and improving success rate of access to the coronary sinus, according to a study presented at EHRA EUROPACE - CARDIOSTIM (21-24 June, Milan, Italy).

LuxCath LLC awarded US patent for real-time lesion visualisation technology for...

The LuxCath LLC system determines electrode-tissue contact as well as monitors lesion progression during ablation and provides real-time lesion visualisation without pressure sensors or ultrasound.

Biotronik single- and dual-chamber pacemakers and ICDs approved for use in...

A press release states that the company is now the only one offering both implantable cardioverter-defibrillators (ICDs) and pacemakers approved for 3T scans.

Cardiome partner Eddingpharm to initiate Brinavess phase I study in China

The study will be conducted in healthy volunteers. If Brinavess successfully completes phase 1, Eddingpharm anticipates initiating a pivotal phase 3 study by year end.

ESC announces hot line sessions highlights

Key topics from the hot line sessions of ESC 2015 include atrial fibrillation, pacing, acute myocardial infarction, heart failure, hypertension, diabetes mellitus, pharmacology and coronary artery disease.

Biotronik announces first implantation of Itervia HF-T QP devices

Itrevia HF-T QP includes the Closed Loop Stimulation (CLS) algorithm, capable of adapting heart rate in response to physiological demands independent of body movements or respiratory rate.

Black Americans are at greater risk for sudden cardiac arrest than...

Black Americans are more likely to experience sudden cardiac arrest and at a much earlier age than their white compatriots, according to research published in Circulation.

Off-label use of the Lariat device for left atrial appendage exclusion...

A Food and Drug Administration (FDA) announcement and a study in JAMA Internal Medicine about use of the Lariat suture delivery device (SentreHeart) for left atrial appendage (LAA) closure have raised questions regarding using the device in this off-label indication.

Highlights EHRA EUROPACE-CARDIOSTIM 2015: Interview with Michael Glikson

Michael Glikson (director of Davidai Arrhythmia Center, Heart Center, Sheba Medical Center, Tel Hashomer, Israel), vice-chairperson scientific programme for EHRA EUROPACE-CARDIOSTIM 2015, talks to Cardiac Rhythm News about the highlights of this years' congress.

Air pollution from wildfires may increase risk for cardiac arrest

Exposure to fine particle air pollution during wildfires may increase risk for cardiac arrest and other acute heart problems, particularly in the elderly, a new study has found.

More than half of breast cancer patients develop diastolic dysfunction after...

A new study reports that within 12 months of completing anthracycline treatment, 57% of breast cancer patients had changes on their echocardiograms consistent with diastolic dysfunction.

FDA reports adverse events with the Lariat device for left atrial...

The US Food and Drug Administration has issued a safety communication to healthcare providers reporting deaths and serious adverse events with the use of the Lariat Suture Delivery Device (SentreHeart) and its associated devices used for left atrial appendage closure.

Hansen Medical announces enrolment of initial cohort in ARTISAN US clinical...

The trial will evaluate the safety and effectiveness of the Sensei robotic system and Artisan family of catheters for introducing and positioning radiofrequency ablation catheters in patients with symptomatic, drug-refractory paroxysmal atrial fibrillation.

LCZ696 (Entresto) gets FDA approval for heart failure treatment

Novartis has announced that the US Food and Drug Administration (FDA) has approved Entresto (sacubitril/valsartan) tablets, previously known as LCZ696, for the treatment of heart failure with reduced ejection fraction.

Racial and gender disparities in care exist for patients newly-diagnosed with...

New study published in HeartRhythm shows differences in the utilisation of atrial fibrillation therapies in a large nationwide population.

Biotronik announces start of BIOWOMEN study

First patient enrolled in global clinical investigation into differences in gender response to cardiac resynchronisation therapy.

New research outlines more effective diagnosis for people with heart conditions

Michael Gallimore, from the School of Engineering at the University of Lincoln, UK, and colleagues have created a new algorithm which produces more accurate electrocardiogram (ECG) signal classification when tested on patients.

Less than 10% of eligible older patients receive an ICD after...

Sean D Pokorney (Durham, USA) and others report in JAMA that only 8.1% of older patients who are eligible to receive an implantable cardioverter defibrillator (ICD) after a myocardial infarction actually do so. The authors also found that older age did not appear to affect the mortality benefit that is associated with ICD implantation.

Multicentre study in patients shows idarucizumab reverses anticoagulant effect of dabigatran...

An interim analysis of the phase III RE-VERSE AD patient study demonstrates that 5g of the antidote idarucizumab reversed the anticoagulant effect of dabigatran within minutes in patients with serious bleeding complications or requiring urgent procedures.

Sorin and Cyberonics unveil name of combined company: LivaNova

Until the closing of the transaction, expected in the third calender quarter of 2015, both companies will continue to operate separately under their current brand names and leadership structures.

FDA approves trial to evaluate Lariat ligation of the left atrial...

The randomised, controlled AMAZE trial, will evaluate the use of the Lariat device for the ligation of the left atrial appendage as an adjunctive treatment to ablation in patients with persistent or long-standing persistent atrial fibrillation.

Medtronic announces US launch of Advisa SR MRI SureScan pacing system

The Advisa SR MRI SureScan single-chamber pacemaker with the 5076 MRI lead allows for magnetic resonance imaging (MRI) scans positioned on any region of the body without restrictions.

Andexanet alfa significantly reduces bleeding in a validated animal model using...

The reduction in blood loss correlated with reversal of the anticoagulant effects of rivaroxaban as measured by anti-Factor Xa activity.

First ESC recommendations for arrhythmias and chronic kidney disease published

The first ESC recommendations for patients with cardiac arrhythmias and chronic kidney disease (CKD) were presented at EHRA EUROPACE - CARDIOSTIM 2015 (21-24 June, Milan, Italy) and published in EP Europace.

Edoxaban approved in the European Union

Edoxaban (Lixiana, Daiichi Sankyo) is an oral, once-daily selective factor Xa-inhibitor for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors.

Fibrin and stem cell patches show promise for heart healing

findings of a study demonstrate the promise in regenerating cardiac tissue using engineered patches made up of a mixture of fibrin and mesenchymal stem cells (MSCs) derived from human umbilical cord blood.

Patients “test drive” pacemaker before choosing permanent implant

Patients are "test driving" a pacemaker outside the skin before deciding whether to have a permanent implant, according to research presented at EHRA EUROPACE-CARDIOSTIM by Michael Giudici, University of Iowa Hospitals and Clinics, USA.

ESC recommends uninterrupted vitamin K antagonists during ablation and device implantation

The recommendations are an update of EHRA's 2008 consensus document, which required an update due to dramatic changes in the field during the last five years.

Cecilia Linde

Cecilia Linde speaks to Cardiac Rhythm News about her work on a research platform for new onset heart failure in Stockholm, the highlights of this year's EHRA EUROPACE - Cardiostim Congress and her views on what is needed to improve cardiac care in Europe.

Boston Scientific initiates study to assess Emblem S-ICD in primary prevention...

The UNTOUCHED study will compare outcomes during an 18-month follow-up period to objective performance criteria derived from the MADIT-RIT study, which evaluated shock rates in 1,500 patients implanted with transvenous ICD devices.

Medtronic Micra transcatheter pacemaker meets initial safety and performance measures

The data from a global clinical trial involving the miniaturised device were presented at a late-breaking clinical trials session at EHRA EUROPACE-CARDIOSTIM 2015 (21-24 June, Milan, Italy).

One-year outcomes on stroke prevention in patients with newly-diagnosed atrial fibrillation...

Real-life data on stroke prevention from 17,200 patients will provide information on how patient risk profiles and quality of vitamin K antagonist control are associated with increased mortality and stroke in patients with newly diagnosed atrial fibrillation.

AliveCor announces availability of its Mobile ECG in Canada

The AliveCor Mobile ECG and the AliveECG app allows users to detect the presence of atrial fibrillation in an electrocardiogram (ECG or EKG) and manage their heart health with an electrocardiogram ECG monitor.

Medtronic acquires CardioInsight Technologies

CardioInsight Technologies will now become part of the Medtronic Atrial Fibrillation Solutions business in the Cardiac Rhythm and Heart Failure division.

Biosense Webster launches Carto 3 system Confidense module

The Confidense module's proprietary algorithm streamlines data collection, annotation and validation for the market-leading Carto system.

Benefit of anticoagulation in AF patients with a low risk of...

The results from a retrospective study, based on a large dataset (over 140,000 patients), have cast doubt on the benefit of routine oral anticoagulants for patients with atrial fibrillation and low risk of stroke.

Don’t miss Europe’s largest congress dedicated to cardiac arrhythmias

In June 2015, cardiac rhythm specialists will gather in Milan, Italy, to learn, share and discuss the latest advances in cardiac arrhythmias treatment in the largest European congress in the field: EHRA EUROPACE-CARDIOSTIM.

InvisionHeart receives FDA 510(k) clearance of its InvisionECG technology

The InvisionHeart ECG system provides a mobile solution for capturing and managing 12-lead ECGs, including the ability to read and visually compare, confirm, report and store diagnostic quality electrocardiograms.

AliveCor launches updated app providing Heart Journal

The Heart Journal is a feature that allows users to log and tag daily activities, symptoms and events in real-time that can impact heart health and work to identify abnormalities.

American Heart Association survery indicates potentially dangerous misconceptions about heart failure

The data from the American Heart Association will inform ongoing efforts and outreach about heart failure in the USA.

Baku 2015 equips European Games with Zoll AED Plus to treat...

Eighty AED Plus units will be distributed among the mobile medical teams and be available across all Baku 2015 venues.

Study published in The Lancet shows effective reversal of dabigatran in...

A study in healthy volunteers investigating the reversal of the anticoagulant effect of dabigatran etexilate (Pradaxa, Boehringer Ingelheim) by its specific agent idarucizumab has shown the antidote led to immediate, complete and sustained reversal of the anticoagulant effect.

Intravenous vernakalant facilitates electrical cardioversion in patients with cardioversion-resistant atrial fibrillation

intravenous vernakalant facilitated successful electrical cardioversion in patients who had failed to attain sinus rhythm following failed electrical cardioversion, or who immediately returned to atrial fibrillation after briefly attaining sinus rhythm.

Michael Gold

William Gold spoke to Cardiac Rhythm News about his involvement in various clinical trials, his views on the upcoming treatment options for heart failure and the highlights of this year's HRS meeting.

Report highlights urgent action needed to lessen the future impact of...

Report recommendations aim to improve management of atrial fibrillation as numbers are expected to double from 8.8 to 17.9 million adults aged over 55 years between 2010 and 2060.

Medtronic Tyrx antibacterial envelope reduces cardiac device infection rates at 12...

Long-term Citadel/Centurion clinical trial findings and independent data presented at Heart Rhythm Society 36th Annual Scientific Sessions.

Medtronic receives FDA approval and CE mark for Arctic Front Advance...

The third-generation cryoballoon is designed to allow enhanced positioning and help improve capture of real-time data with achieve mapping catheter.

New data show safety and efficacy of specifically designed implantable cardioverter...

Early performance results of the first-in-human international study of Medtronic's Micra Transcatheter Pacing System (TPS) have demonstrated the device is safe and effective.

First patient enrolled in dabigatran study comparing anticoagulation strategies during atrial...

dabigatran
The study assesses the safety and efficacy of uninterrupted anticoagulation with dabigatran etexilate (Pradaxa) during ablation procedures compared to warfarin. Results from the study are expected during 2016.

Cryoballoon ablation is not as safe as radiofrequency but is as...

Armin Luik presented findings at HRS 2015 indicating that cryoballoon ablation is a faster as effective as radiofrequency ablation for pulmonary vein isolation in paroxysmal atrial fibrillation patients, but has a greater complication rate and requires higher X-ray dosages.

Safety and efficacy of Transcatheter Pacing System demonstrated in initial study

Early performance results of the first-in-human international study of Medtronic's Micra Transcatheter Pacing System (TPS) have demonstrated the device is safe and effective.

Botox reduces AF burden for up to a year after cardiac...

Botulinum toxin injected into epicardial fat pads during coronary artery bypass graft surgery reduced the incidence of postoperative atrial fibrillation compared with placebo, with substantial suppression persisting after one year, a pilot study has found.

Cardiac resynchronisation is possible by leadless endocardial pacing of the left...

Results from the prospective, non-randomised, multicentre SELECT-LV trial were presented at the Heart Rhythm Society 36th Annual scientific Sessions and demonstrated promising efficacy and safety data.

Baroreflex activation therapy shows greater benefits in no-CRT heart failure patients

A phase II study onbaroreflex activation therapy treatment for heart failure patients with a reduced ejection fraction has found greater benefits for patients without a cardiac resynchronisation therapy device than for patients with one.

Activity after ICD implantation may predict survival

In the largest study on the relationship between activity and survival in ICD patients, researchers analysed how active participants were in the first 30-60 days after implantation and then over time up to four years.

Global trial finds Medtronic Micra transcatheter pacemaker meets initial safety measures...

All of the first 140 patients in the trial were successfully implanted with the Micra TPS. The data were presented at Heart Rhythm 2015 (13-16 May, Boston, USA).

Data shows advantages of Acutus Medical Dipole Density Heart Imaging and...

The data was presented at the Heart Rhythm Society's 36th Annual Scientific Sessions (13-16 May, Boston, USA) and shows the systems benefits compared with standard voltage-based mapping in patients with atrial flutter.

HeartLight US pivotal study meets primary efficacy and safety endpoints

The trial, which randomised CardioFocus' HeartLight one-to-one versus the Biosense Webster Thermocool catheter, met both primary efficacy and safety endpoints and demonstrated a low learning curve for physicians.

Abbott and GE Healthcare announce agreement to improve atrial fibrillation treatment

The agreement will bring real-time, patient-specific heart electrical activity data to cardiac electrophysiology labs around the world to speed up the diagnosis of the sources of atrial fibrillation and other heart rhythm disorders.

St Jude Medical expands portfolio of MRI-compatible devices to high voltage...

St Jude Medical has received CE mark approval of expanded labelling for its Ellipse implantable cardioverter defibrillator and its Durata and Optisure defibrillation leads. It has received CE mark approval for its Assurity MRI and Endurity MRI pacemaker device families.

Medtronic initiates study of in-office insertion of Reveal LINQ cardiac monitor

RIO 2 study evaluates safety and effectiveness of moving the insertion procedure from hospital to office setting.

First-in-human study backs neuromodulation to treat paroxysmal atrial fibrillation

A first-in-human study shows low level transcutaneous electrical vagus nerve stimulation, a completely non-invasive approach, suppresses paroxysmal atrial fibrillation.

No additional shocks or hospitalisations: Study shows home exercise safe after...

The results of a prospective, randomised trial demonstrate that moderately strenuous aerobic exercise, performed at home, for a select group of implantable cardioverter defibrillator (ICD) recipients was highly beneficial at improving cardiovascular performance. Importantly, the exercise did not compromise safety.

Biotronik gets CE mark approval for CardioMessenger Smart device to improve...

New device allows for earlier therapy adjustments in heart patients with pacemakers, implantable cardioverter-defibrillators, cardiac resynchronisation therapy and BioMonitor devices.

Bystander CPR helps cardiac arrest survivors return to work

In the largest study to date to examine return to work after cardiac arrest, researchers studied 4,354 patients in Denmark who were employed before they suffered out-of-hospital cardiac arrests between 2001 and 2011.

Japanese market release of Iperia 7 VR-T DX ProMRI

Japan is the world's largest MRI market with more MRI scanners per capita than any other country: approximately 47 registered machines per one million people.

New test predicts sudden cardiac death in haemodialysis patients

Patients with two or three of the predictors had a sudden cardiac death risk that was 145-times greater than patients with normal levels on all three measures.

Harvard Clinical Research Institute named as a data analytic centre for...

The PINNACLE Registry is a cardiological outpatient quality improvement registry, which collects data about patients in participating cardiology practices to help providers evaluate and improve their adherence to current guidelines.

Middle-aged congenital heart disease survivors may need special care

For the first time, the American Heart Association has issued recommendations for healthcare providers treating people older than 40 with congenital heart disease.

Atrial fibrillation recurrence lower with sleep apnoea treatment

The use of continuous positive airway pressure was associated with a significant reduction in the recurrence of atrial fibrillation in patients with obstructive sleep apnoea, according to a new analysis of data.

Long-term data show safety and efficacy of Boston Scientific’s S-ICD System

The S-ICD System was shown to convert more than 98% of heart arrhythmias that can lead to sudden death. These data are comparable to efficacy outcomes found in transvenous ICD (TV-ICD) clinical trials (95-99%).

FDA approves implantable cardioverter defibrillator with ultra-high energy on the first...

New Biotronik DX implantable cardioverter defibrillators with longer battery life and 42 joules on first shock offers "maximum energy", while the Itrevia implantable cardioverter defibrillator series is also approved.

Portola Pharmaceuticals announces positive phase 3 results from the ANNEXA-A study

Data support registration of Andexanet Alfa Bolus-Only and Bolus-Plus-Continuous-Infusion dosing regimens to reverse anticoagulant effect of Factor Xa Inhibitors.

CVRx Barostim Therapy clinical trial results to be presented at Heart...

Safety and efficacy results comparing patients previously treated with cardiac resynchronisation therapy to patients without cardiac resynchronisation therapy will be presented by Michael Zile from the Medical University of South Carolina, USA.

HeartWare achieves primary endpoint in the ENDURANCE destination therapy clinical trial

Investigators report data from first cohort in destination therapy at the 35th annual International Society for Heart and Lung Transplantation Meeting in Nice, France.

Edoxaban approved for prevention of stroke and systemic embolism in non-valvular...

Daiichi Sankyo has announced that Swissmedic, the regulatory authority of Switzerland, has granted approval of Lixiana (edoxaban), an oral, once-daily selective factor Xa inhibitor, for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation and treatment of venous thromboembolism in deep vein thrombosis.

Study re-examines sports restrictions for children with heart rhythm disorder

The study, published in JACC: Clinical Electrophysiology, found that the benefits of participation may outweigh risks for children with heart conditions.

Medtronic’s Micra Transcatheter Pacing System gets CE mark

The device is less than one-tenth the size of traditional pacemakers and is delivered with minimally invasive techniques through a catheter, and implanted directly into the heart.

AATS Graham Foundation and AtriCure announce James L Cox Fellowship in...

Fellowship provides newly-graduated cardiothoracic surgeons with a unique opportunity to be trained by nationally recognised experts in atrial fibrillation surgery.

Portola Pharmaceuticals announces positive results for phase 3 ANNEXA-A trial of...

Portola Pharmaceuticals has announced positive topline results from the second part of the phase 3 ANNEXA-A study, which evaluated the safety and efficacy of andexanet alfa, an investigational antidote, with the Factor Xa inhibitor apixaban.

Adding atrial fibrillation ablation to mitral valve surgery significantly increases risk...

A new study has found that a combination of surgical atrial fibrillation ablation and mitral valve surgery in patients with persistent or long-standing persistent atrial fibrillation is associated with a significantly increased rate of freedom from atrial fibrillation at one year. However, it is also associated with a significantly increased rate of pacemaker implantation.

Catheter ablation superior to amiodarone for patients with persistent atrial fibrillation...

Speaking at the 2015 American College of Cardiology Annual Scientific Session, Luigi Di Biase reported that-compared with the antiarrhythmic drug amiodarone-catheter ablation significantly increases the rate of freedom of recurrence in patients with persistent atrial fibrillation and heart failure.

First fully-implantable micropacemaker designed for foetal use

Researchers in the USA have developed the first fully-implantable micropacemaker designed for use in a foetus with complete heart block. The micropacemaker has been designated a humanitarian use device by the US Food and Drug Administration (FDA).

Biotronik announces first patient implanted with Eluna pacemaker system with full-body...

Biotronik has announced that the first US patient has been implanted with the company's Eluna pacemaker system with ProMRI technology.

Physically active middle-aged adults have low risk of sudden cardiac arrest

A review of 1,247 sudden cardiac arrest cases involving men and women ages 35-65 revealed that 63 cases (5%) were associated mainly with sports activities.

First patient enrolled in the GOLD AF registry of Medtronic’s PVAC...

Medtronic has announced the first patient enrolment in the GOLD AF registry, a first-of-its-kind, prospective, observational clinical study of its Phased Radiofrequency (RF) Ablation technology for treating patients with symptomatic atrial fibrillation.

Gender, age and mood disorders affect how patients perceive atrial fibrillation...

First-of-its-kind study published in HeartRhythm assesses various factors that lead to inaccurate detection of the frequency and duration of atrial fibrillation episodes.

Long-term sustained weight loss associated with significant reduction in AF burden

The first study investigating the long-term effects of weight loss and the degree of weight fluctuation on atrial fibrillation (AF) burden has found that obese patients with this arrhythmia who lost at least 10% of their body weight were six times more likely to achieve long-term freedom from atrial fibrillation.

FDA approves Biotronik Eluna pacemaker system with full-body ProMRI technology

Biotronik's ProMRI technology allows patients to undergo full-body magnetic resonance imaging (MRI) scans with both single-chamber and dual-chamber Eluna pacemakers when implanted with Setrox pacing leads.

CorMatrix CanGaroo ECM Envelope gets approval for South America

CorMatrix announced that it has received international approval from Argentina's National Administration of Drugs, Foods and Medical Devices (ANMAT) to market the CorMatrix CanGaroo ECM Envelope. canga

Arca biopharma provides GENETIC-AF clinical trial update

The GENETIC-AF phase 2B/3 clinical trial is evaluating Gencaro (bucindolol hydrochloride) as a potential treatment for atrial fibrillation.

Data shows ProMRI pacemakers to be safe and effective in full-body...

William M Bailey, medical director of Louisiana Heart Rhythm Specialists in Lafayette, discussed new clinical data at the American College of Cardiology's 64th Annual Scientific Sessions in San Diego.

Boston Scientific announces FDA and CE mark approval of the Emblem...

The Emblem S-ICD system is 19% thinner and is projected to last 40% longer than the previous system, improving patient comfort and cosmetic outcomes while reducing the number of times the device will require replacement.

Many atrial fibrillation patients at high risk of stroke fail to...

First phase II data demonstrating anticoagulant prescribing patterns in North America now available from GLORIA-AF Registry programme.

Cleveland Heart International and CU Medical roll out external defibrillator technology...

Cleveland Heart International to acquire majority interest in Korean automatic external defibrillators manufacturer CU Medical.

ResMed to present data on sleep-disordered breathing in chronic heart failure...

Data from the two studies will be presented at the 64th Annual Scientific Sessions of the American College of Cardiology (ACC) (14-16 March, San Diego, USA).

ACC releases updated training recommendations for cardiology fellows

This latest version defines cardiology core competencies for the first time.

Societies release revised training guidelines for paediatric cardiology fellowship programmes

The Society of Pediatric Cardiology Training Program Directors, the American College of Cardiology, the American Academy of Pediatrics and the American Heart Association worked to develop the guidelines.

First in-man study of miniaturised implantable cardiac monitor shows positive results

First in-man multicentre study of the miniaturised implantable cardiac monitor Reveal Linq (Medtronic) suggests the device is safe and provides adequate sensing capabilities to detect arrhythmias.

AliveCor launches new app that automatically tells patients when their ECG...

Anytime an ECG is taken with the AliveCor Heart Monitor, the AliveECG app will tell users if atrial fibrillation is present, if the ECG is normal, or if there is too much interference and another ECG should be taken.

Zoll ResQCPR system receives premarket approval from the FDA

The ResQCPR system demonstrated a 49% increase in one-year survival in adult patients who experienced out-of-hospital cardiac arrest of presumed cardiac etiology, as compared to treatment with conventional manual CPR.

TomTec receives FDA 510(k) clearance for its latest version of TomTec-Arena...

TomTec-Arena is a suite of clinical applications to review, analyse and quantify medical image data in multiple dimensions (2D and 3D/4D) and multiple modalities.

Updated US guidelines suggest an increase by 19% in AF patients...

Two-thirds of patients who were not previously recommended for oral anticoagulation therapy are now recommended, according to an assessment of the 2014 AHA, ACC and HRS atrial fibrillation guidelines.

Atrial fibrillation patients on digoxin face increased risk of death

Analysis of 19 studies finds atrial fibrillation patients taking digoxin are 27% more likely to die than those who do not.

Global atrial fibrillation treatment market to peak at US$9.4bn in 2020

The market will more than double in value from US$4.6bn in 2013 to US$9.4bn in 2020, before declining to US$5.7bn by 2023, according to research and consulting firm GlobalData.

London Bridge Hospital partners with Quail Digital to enhance clinical communications...

Quail's wireless headset system will provide hands-free communications between the treatment lab and monitoring room, which are separated by insulated partitions and glass.

Boehringer Ingelheim submits biologics license application to FDA for reversal agent...

Boehringer Ingelheim has announced it has submitted a biologics license application to the FDA, requesting an Accelerated Approval pathway, for the use of idarucizumab to reverse the anticoagulant effect of dabigatran.

Cyberonics and Sorin announce merger plan

Sorin and Cyberonics have announced their merger plan with a combined equity value of approximately US$2.7bn (€2.4bn).

Spinal cord stimulation in severe heart failure patients is safe and...

Results of a prospective, multicentre pilot trial of severe heart failure patients treated with continuous spinal cord stimulation have shown the treatment is safe and feasible with the Eon Mini neurostimulation device (St Jude Medical) and can potentially improve symptoms, functional capacity and cardiac function.

Vitaria vagal nerve stimulation system receives CE mark for treatment of...

Vitaria delivers autonomic regulation therapy for patients who have moderate to severe heart failure with left ventricular dysfunction (ejection fraction < 40%), and who remain symptomatic despite stable, optimal heart failure drug therapy.

Subcutaneous-ICD patients may be able to undergo MRI scans at 1.5T...

Subcutaneous implantable cardioverter-defibrillator patients may be safe to be exposed to magnetic resonance imaging (MRI) procedures at 1.5T with a pre-specified scanning and monitoring protocol.

Heart failure patients who struggle with daily tasks are hospitalised more...

The risk is higher for older women, unmarried people and those with chronic conditions that affect mobility and ability, including obesity, dementia, anaemia and diabetes, researchers said.

First patients enrolled in DEEP clinical study

The study is the first-of-its-kind in the USA exploring a minimally invasive epicardial surgical ablation approach combined with an endocardial catheter-based ablation approach for the treatment of persistent or long-standing persistent atrial fibrillation.

Heart-failure helpline could be “difference maker” for turning disease into a...

The Stronger Hearts Helpline pilot programme centralises resources to educate and improve access to care.

CHU de Saint- Étienne launches second stereotaxis lab

With the launch, the hospital becomes the first in Europe to operate two Niobe systems for clinical procedures.

New data shows iRhythm reduces cost of arrhythmia detection compared to...

The study, which was funded by iRhythm, suggests that the lack of diagnosis after the initial use of the Holter monitor resulted over US$23,000 per patient in wasted spending by Medicare.

ProMRI studies confirm safety of MR imaging with Biotronik devices

Studies validate safety of Biotronik ProMRI devices in patients subjected to head and lower lumbar 1.5T MRI scans.

Real-world study shows effectiveness of Reveal LINQ to detect atrial fibrillation...

New data demonstrate cost-effectiveness of long-term, continuous cardiac monitoring with potential to prevent recurrent strokes.

Stem cells from placenta show promise for treating heart failure

A new study has examined the therapeutic effects of PDA-001, an intravenous formulation of PDAC cells, in mice, as well as the best way to deliver the therapy.

Sorin announces enrolment of first patients in the Vanguard clinical study

The Vanguard (Vagal nerve stimulation safeguarding heart failure patients) clinical study evaluates Equilia, a neurostimulation system for heart failure patients.

Real-world multicentre study shows positive outcomes with left atrial appendage occlusion...

The largest study using the Amplatzer Cardiac Plug (St Jude Medical) for left atrial appendage occlusion has shown a high procedural success rate and favourable outcomes for prevention of atrial fibrillation-related thromboembolism.

Hansen Medical announces expanded protocol for the ARTISAN-AF IDE study

The amended protocol now includes the use of the Thermocool SmartTouch catheter (BioSense Webster) and the EnSite Velocity Cardiac Mapping System (St Jude Medical) in combination with the Sensei Robotic System (Hansen Medical) for the treatment of paroxysmal atrial fibrillation.

FDA approves Savaysa for reduction of stroke risk in non-valvular atrial...

Savaysa (edoxaban) is an oral, once-daily selective factor Xa inhibitor, designed to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation

Wearable sensor smoothes path to long-term ECG and EMG monitoring

The new sensor is as accurate as the "wet electrode" sensors used in hospitals, but can be used for long-term monitoring and is more accurate than existing sensors when a patient is moving.

Phase 3 ANNEXA-R study of andexanet alfa and factor Xa inhibitor...

rivaroxaban
Andexanet alfa is the only universal factor Xa inhibitor antidote shown to directly reverse the anticoagulant activity of these agents in clinical studies.

Hung-Fat Tse

While Hung-Fat Tse's initial research interests focused on device therapy for cardiac arrhythmias, he has dedicated his career to the development of cardiovascular regenerative medicine.

Boston Scientific launches long-lasting implantable cardioverter defibrillators

The devices feature EnduraLife battery technology developed with high-performance chemistry and advanced manufacturing capabilities to provide up to double the battery capacity of other defibrillators.

CVRx Barostim Therapy trial results to be presented at the ACC...

CVRx completed enrolment of the 146-patient clinical trial to determine the performance of Barostim Therapy for patients suffering from chronic heart failure with advanced symptoms.

FDA clears AliveCor’s new automated detectors for normal ECG recordings and...

AliveCor's new algorithms include a Normal Detector that identifies when no abnormalities are detected in an ECG recording and an Interference Detector that identifies if factors have affected the recording making the ECG unreadable.

Bridging during anticoagulation interruption associated with higher bleeding risk in AF...

A subanalysis from the ORBIT-AF registry has found that atrial fibrillation patients who receive bridging anticoagulation therapy during anticoagulation interruption are at higher risk of bleeding and adverse events following interruption than patients who do not receive bridging anticoagulation.

Bayer collaborates on phase III study to evaluate Xarelto in embolic...

rivaroxaban
In addition, Xarelto (rivaroxaban) label now includes guidance for use in patients with atrial fibrillation undergoing cardioversion.

St Jude Medical announces FDA approval of FlexAbility Ablation Catheter

The FlexAbility catheter features a handle and shaft combination that allows for improved maneuverability, enabling electrophysiologists to reach challenging anatomic locations within their patients' hearts.

AliveCor launches atrial fibrillation algorithm detector for its Heart Monitor

The latest version of the AliveECG app for users in the United Kingdom and Ireland now provides patients with real-time atrial fibrillation detection in electrocardiogram recordings using the AliveCor Heart Monitor.

Ten per cent of heart patients may be inappropriately prescribed aspirin

Accessing data from the National Cardiovascular Disease Registry PINNACLE Registry, researchers examined a nationwide sample of 68,808 patients receiving aspirin for primary cardiovascular disease prevention.

Biotronik concludes enrolment in phase C of its ProMRI ICD Study

The ProMRI study consists of a series of MRI compatibility trials intended to increase cardiac device patients' access to MRI.

Milestone Pharmaceuticals receives FDA clearance of MSP-2017 phase 2 IND

The trial design cleared by FDA is a multiple arm phase 2, multicentre, placebo-controlled study of intranasal administration of MSP-2017 for the conversion of PSVT to sinus rhythm.

St. Jude Medical begins study of ablation procedures to treat ventricular...

The FlexAbility ablation catheter will be used to assess benefits of catheter ablation as an adjunctive therapy for patients at risk for life-threatening arrhythmias.

Medtronic initiates European trial to evaluate cryoballoon ablation treatment for atrial...

Cryoablation creates lesions by freezing tissue in the heart's upper chambers, traditionally around the pulmonary veins, to block the electrical signals that trigger erratic heart rhythms.

Medtronic announces first patient enrolment in Tyrx absorbable antibacterial envelope trial

The trial will evaluate the effectiveness of the Tyrx absorbable antibacterial envelope in reducing major infections in patients with cardiac implantable electronic devices at risk of infection.

Stereotaxis receives FDA clearance of Vdrive system and Japanese regulatory approval...

The Vdrive allows physicians to remotely control the advancement, retraction and rotation of a compatible fixed curve transseptal sheath, in conjunction with a magnetic ablation catheter.

Abbott completes acquisition of Topera

Abbott has acquired all outstanding equity of Topera for US$250m upfront, plus potential future payments tied to performance milestones.

Biosense Webster launches programme to reinforce patient benefits of company’s contact...

The Biosense Webster Advantage programme is an outcomes-based, risk-sharing program for US hospitals that reinforces the significant patient benefits demonstrated by the ThermoCool SmartTouch Catheter.

AliveCor launches third generation heart monitor

AliveCor says that the third generation device is 50% thinner and 40% lighter and was designed from first-hand customer feedback and in collaboration with global design firm IDEO.

Philips’ defibrillators to be made available to schools across the UK

Philips secures nationwide Department for Education tender to provide schools with the latest HeartStart FRx automated external defibrillators.

REPLACE DARE score provides tool for risk stratifying pacemaker or implantable...

Analysis of Biotronik-sponsored REPLACE registry identifies key patient risk factors and reveals comorbidities more relevant than procedure-related complications.

The challenge of left ventricular lead placement: What is the role...

George H Crossley (Nashville, USA) writes on the role of quadripolar leads in cardiac resynchronisation therapy to treat heart failure patients.

Non-invasive mapping prior to ablation may be an effective strategy for...

Preliminary data from the AFACART study have shown encouraging results when treating persistent atrial fibrillation with non-invasive mapping followed by pulmonary vein isolation and/or linear lesions.

First trial of oral anticoagulant to prevent recurrent stroke due to...

The first patient has been enrolled in the RE-SPECT ESUS phase III study to investigate the efficacy and safety of dabigatran etexilate for the prevention of recurrent embolic stroke of undetermined source.

Guidelines added to ACC Guideline Clinical App

The American College of Cardiology's recently-released Guideline Clinical App has expanded with the addition of tools and guideline content for valvular heart disease and atrial fibrillation.

St Jude Medical receives CE mark approval of the Allure Quadra...

The Allure Quadra MP cardiac resynchronisation therapy pacemaker contains MultiPoint Pacing technology, which enables physicians to pace multiple locations on the left ventricle, giving the clinician more choices to best optimise CRT pacing based on patient need and reducing the rate of CRT non-responders.

Medtronic receives FDA approval and launches additional Attain Performa leads

The newest additions to the Attain Performa lead portfolio are designed to accommodate patients' varying vessel sizes and curvatures to enhance successful lead placement.

Biotronik announces conclusion of full-body ProMRI pacemaker study

Phase B of Biotronik's ProMRI study has completed patient enrolment and concluded all planned scans.

New research reports low rate of mechanical failure in Optim family...

A new study evaluating Optim-insulated implantable cardioverter defibrillator leads found low rates of all-cause mechanical failure during a median follow-up of 3.2 years.

iRhythm Technologies receives CE mark for ZIO Service and enters UK...

iRhythm Technologies has secured a CE mark for the ZIO Service, enabling the company to market its long-term continuous heart monitoring solution in Europe.

Biotronik launches new ProMRI ICD and CRT-D series with Sentus QP...

Biotronik has launched its new series of single- and dual-chamber implantable cardioverter defibrillators and cardiac resynchronisation therapy defibrillators.

Epinephrine may do more harm than good for cardiac arrest patients

For patients in cardiac arrest, administering epinephrine may increase the overall likelihood of death or debilitating brain damage, according to a study published in the Journal of the American College of Cardiology.

Ventricular tachycardia treatment with robotic catheter ablation shows positive results

A study undertaken in the UK has shown that radiofrequency ablation of scar-related ventricular tachycardia, using robotic navigation, is safe and feasible and has resulted in 95% reduction in total implantable cardioverter defibrillator (ICD) therapy burden at six months.

European cardiologists highlight risk of delayed diagnosis for patients with non-valvular...

A new survey has found that despite an increase in the number of non-valvular atrial fibrillation patients compared to five years ago, the majority of cardiologists believe there is a delay in patients reaching diagnosis.

Investigational idarucizumab may reverse effect of dabigatran, new data show

New data on the investigational antidote idarucizumab show that it may reverse the effect of the oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) on both blood coagulation and the blood clotting mechanism.

Drug helps lower high potassium levels associated with potentially lethal cardiac...

Mikhail Kosiborod, of Saint Luke's Mid America Heart Institute, Kansas City, and colleagues evaluated the efficacy and safety of the drug zirconium cyclosilicate in patients with hyperkalemia (higher than normal potassium levels).

Biotronik releases new online tool to track MR conditional status of...

Biotronik has launched ProMRI SystemCheck, a new online tool for tracking the ProMRI status of implantable devices.

Long-term overtreatment with antiplatelet/anticoagulant therapy may increase the risk of dementia...

Atrial fibrillation patients who are receiving a combination of antiplatelet and anticoagulant therapy and are over treated with warfarin may be at an increased risk of dementia, according to a study presented at the American Heart Association's Scientific Sessions (AHA;15-19 November, Chicago, USA).

Algisyl-LVR shows significant health status improvement of advanced heart failure patients

LoneStar Heart has presented the primary six month results of its multicentre, randomised clinical trial of Algisyl-LVR, providing evidence that the cardiac hydrogel implant can prevent or reverse the symptoms of moderate to severe heart failure in patients with a dilated and weakened left ventricle.

CardioMEMS HF significantly reduces 30-day hospital readmission rates

Retrospective data analysis from the CHAMPION clinical trial shows significant reduction in 30-day hospital readmission rates for heart failure patients age 65 and older treated with the CardioMEMS HF system (St Jude Medical).

Studies show Medtronic CRT devices reduce readmissions after heart failure hospitalisations

New data from Medtronic show that its cardiac resynchronisation therapy devices for the treatment of heart failure can cause a significant reduction in all-cause 30-day readmissions after heart failure hospitalisations.

Highlights from ISCAT 2014

Michel Haissaguerre and Etienne M Aliot, chairmen of the International Symposium on Catheter Ablation Techniques (ISCAT; 15-17 October 2014, Paris, France), discuss the highlights of this year's meeting with Cardiac Rhythm News.

New positive data from investigational drug (LCZ696) for heart failure presented...

New data from PARADIGM-HF have shown that the investigational angiotensin receptor-neprilysin inhibitor (ARNI) LCZ696 (Novartis) has the potential to prevent the clinical progression of surviving patients with heart failure more effectively than enalapril.

Biosense Webster and StopAfib.org work to raise awareness of AFIB

Biosense Webster has partnered with advocacy organisation StopAfib.org to encourage Americans to "Get SMART About Afib."

Watchman presents possible alternative to warfarin for stroke prevention in patients...

Study examines the long-term efficacy and safety of Boston Scientific's Watchman device to achieve left atrial appendage closure in patients with atrial fibrillation.

Study recommends repeat testing of Brugada syndrome patients

A study has investigated the clinical significance of repeat testing after puberty in asymptomatic children with a family history of Brugada syndrome who had an initial negative test earlier in childhood.

Survey uncovers need to raise awareness of link between atrial fibrillation...

A survey issued by the Heart Rhythm Society and National Stroke Association in collaboration with Boehringer Ingelheim has found there are information gaps regarding the impact of AF-related stroke - among AF patients, physicians and caregivers - including communication barriers, challenges with patient education, misperceptions about treatment compliance, and outcomes related to the impact of stroke on one's life.

Stressful duties linked with risk of sudden cardiac death among police...

Stressful and physically-demanding law enforcement activities are associated with large increases in the risk of sudden cardiac death among US police officers compared with routine policing activities.

S-ICD system receives favourable US coding and payment designations for 2015

Boston Scientific has announced that its subcutaneous implantable defibrillator (S-ICD System) will have designated Current Procedural Terminology (CPT) Category I codes by the American Medical Association, effective 1 January 2015.

MiD study unveils key arrhythmia findings in patients with end-stage renal...

Medtronic has announced the results of a new study which found that atrial fibrillation and bradycardia occurred at higher than expected, and clinically significant, rates in patients with end-stage renal disease undergoing haemodialysis.

American College of Cardiology announces launch of JACC: Clinical Electrophysiology

The American College of Cardiology has announced the launch of the Journal of the American College of Cardiology (JACC): Clinical Electrophysiology, which will feature original research and review articles regarding cardiac rhythm disorders.

The challenge of catheter ablation in congenital heart disease patients

Dominic Abrams (Division of Cardiac Electrophysiology, Boston Children's Hospital, Boston, USA) writes on the importance of arrhythmia management in congenital heart disease patients and identifies the reasons why it remains a major challenge for interventional eletrophysiology.

Continuous ECG surveillance of marathon athletes is feasible

Online electrocardiogram (ECG) continuous surveillance during marathon running is feasible, according to a study presented at the European Congress on e-Cardiology and e-Health (29-31 October, Bern, Switzerland). The proof-of-concept study may allow "instantaneous diagnosis of potentially fatal rhythm disorders" in endurance athletes.

Antiarrhythmic drug vernakalant shows positive results in Asia-Pacific phase 3 clinical...

The study achieved the primary endpoint, showing that 53% of patients with recent onset atrial fibrillation (lasting three hours to seven days) receiving an intravenous dose of vernakalant converted to normal heart rhythm within 90 minutes, compared to 12% of placebo patients.

AtriCure receives FDA approval to start DEEP IDE study

The DEEP study will investigate a minimally invasive approach performed by cardiac surgeons and electrophysiologists to treat patients with persistent or long-standing persistent atrial fibrillation who have failed antiarrhythmic drug therapy.

ACC launches new Guideline Clinical App for cardiologists, general practitioners

The American College of Cardiology (ACA), which has been developing clinical practice guidelines in partnership with the American Heart Association (AHA) for more than three decades, has launched a new Guideline Clinical App to serve as the mobile home for all ACC/AHA guideline content and related tools.

LifeWatch signs agreement to utilise Vital Connect’s HealthPatch MD

LifeWatch AG has signed an agreement with Vital Connect Inc. to utilise its HealthPatch MD as a 1-lead ECG device in its cardiac monitoring business.

Dabigatran associated with higher incidence of major bleeding than warfarin

A study of Medicare beneficiaries suggests that dabigatran (Pradaxa, Boehringer Ingelheim) should be prescribed with caution, especially among high risk patients, as it may be associated with a higher incidence of major bleeding and a higher risk of gastrointestinal bleeding, despite a lower risk of intracranial haemorrhage than warfarin, according to a study published online in JAMA Internal Medicine.

FDA makes recommendation on Daiichi Sankyo’s Savaysa

Daiichi Sankyo has announced that the FDA has recommended approval of once-daily Savaysa (edoxaban) 60mg dosing regimen.

Hansen Medical announces global launch of the Sensei X2 robotic system

Hansen Medical's Sensei X2 robotic system is now commercially available in the USA and European Union.

St Jude Medical receives FDA approval of TactiCath Quartz Contact Force...

St Jude Medical has announced the US Food and Drug Administration (FDA) approval of its TactiCath Quartz irrigated ablation catheter, the company's newest technology that gives physicians a real-time, objective measure of the force that the catheter applies to a patient's heart wall during an ablation procedure.

Vitamin D deficiency increases poor brain function after cardiac arrest

Vitamin D deficiency increases the risk of poor brain function after sudden cardiac arrest by seven-fold, according to research presented at Acute Cardiovascular Care 2014 by Jin Wi.

Heart rate may predict survival and brain function in comatose cardiac...

A study has found that patients with sinus bradycardia during therapeutic hypothermia had a 50-60% lower mortality rate at 180 days than those with no sinus bradycardia.

Abbott to acquire Topera and Advanced Cardiac Therapeutics

Abbott enters the catheter-based electrophysiology market with the announcement of an agreement to purchase Topera and the securement of the rights to purchase Advanced Cardiac Therapeutics (ACT). Both companies develop electrophysiology technologies for the diagnosis and treatment of heart rhythm disorders.

Persistent atrial fibrillation treatment with robotic navigation and contact force sensing...

An international multicentre registry evaluating the role of remote robotic navigation and contact force sensing in persistent atrial fibrillation (AF) treatment has found that, at one year, a higher proportion of patients treated with this modality were free from AF recurrences with a single procedure as compared with both manual/contact force sensing and robotic/no contact force sensing procedures.

Living near major roads may increase risk of sudden cardiac death...

A new study has found that living close to a major road may increase women's risk of dying from sudden cardiac death.

Boston Scientific receives CE mark approval for MRI compatible Accolade pacemakers...

Boston Scientific has announced the CE mark approval for the Accolade pacemaker family and for the Visionist and Valitude cardiac resynchronisation therapy pacemakers (CRT-P) with quadripolar pacing technology.

Medtronic gets FDA approval of pacing lead for full-body MRI scans

Medtronic has announced the US Food and Drug Administration (FDA) approval of its CapSureFix Novus MRI SureScan 5076 lead for use with magnetic resonance imaging (MRI).

Massachussets General Hospital to coordinate new global research initiative in USA...

The Massachusetts General Hospital Institute for Heart, Vascular and Stroke Care has announced participation as coordinating centre in the USA for a new research initiative dedicated to explore the genetic causes of atrial fibrillation as part of the Transatlantic Network of Excellence in Cardiovascular and Neurovascular Research Program.

AtriCure completes enrolment in post approval study for the Synergy Ablation...

AtriCure has announced that enrolment in the ABLATE post approval study (PAS) of its Synergy Ablation System is complete. As 3 October 2014, the ABLATE PAS enrolled 365 patients at 40 hospitals across the United States.

Massimo Santini

Massimo Santini performed the first fulguration of the atrioventricular node of resistant supraventricular tachycardia in Italy; he also implanted a pacemaker in the Italian president Carlo Azeglio Ciampi, 10 years ago. Santini speaks to Cardiac Rhythm News about his views on advances in antiarrhythmic drugs, genetics and cardiac arrhythmias, and ECG screening.

FDA’s Advisory Committee Panel votes in favour of Watchman device

Members of the US Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee have voted in favour of the Watchman left atrial appendage closure (LAAC) device (Boston Scientific), by a close vote of 6 to 5 (with 1 abstention) concluding that the potential benefits of Watchman outweigh the potential risks. The Panel also voted unanimously in favour of the device safety; however, its effectiveness saw unfavourable voting.

Novel protein in heart linked to ventricular arrhythmias

Cardiovascular scientists in the USA have identified in mouse models a protein known as Purkinje cell protein-4 (Pcp4) as a regulator of the heart's rhythm. Additionally, they have found that when the Pcp4 gene is disrupted, it can cause ventricular arrhythmias.

CVRx announces first successful Barostim neo heart failure commercial implants in...

CVRx has announced the first 10 heart failure patients treated with the Barostim neo system under CE mark approval.

Radiation risks should be considered and discussed before heart imaging: American...

Before undergoing heart imaging procedures involving radiation, healthcare providers should help patients understand why the procedure is needed and its potential benefits and risks, including risks related to radiation exposure, according to a new scientific statement in the American Heart Association's journal Circulation.

Societies release first appropriate use criteria for paediatric heart disease

The American College of Cardiology, along with eight partnering societies, have released the first appropriate use criteria for suspected heart disease in paediatric patients.

Try something new this world heart day, urges the ESC

Reflecting on the World Heart Day, spokespersons from ESC call for the need to encourage cardiovascular disease prevention through healthy diets and increment of physical activity.

AtriCure launches AtriClip Flex for left atrial appendage occlusion

Atricure has announced the introduction of the AtriClip Flex, a new device used in left atrial appendage occlusion for stroke prevention in atrial fibrillation patients. According to a company release, the device has a more flexible aluminum shaft that allows surgeons to better manoeuvre within a patient's particular anatomy.

St Jude Medical receives CE mark approval for pacing lead labelling...

St Jude Medical has announced CE mark approval of updated labelling for its Tendril STS and IsoFlex Optim pacing leads. The new labelling allows existing and future patients with the devices access to magnetic resonance imaging (MRI) scans.

First randomised sham controlled trial of vagal nerve stimulation for heart...

NECTAR-HF, the first randomised, sham-controlled trial of vagal nerve stimulation for the management of heart failure has failed to show significant difference in cardiac remodelling between vagal nerve stimulation and a sham procedure-meaning that the study has not met its pre-specified six-month primary efficacy endpoint.

AHA and ACC release scientific statement on congenital and genetic heart...

The American Heart Association (AHA) and American College of Cardiology (ACA) have released a statement including 14 key elements that can be used as a checklist for screening young people age 12-25 for congenital and genetic heart disease.

New data analysis from CHAMPION shows significant reductions in heart failure...

St Jude Medical has announced a new data analysis from the CHAMPION clinical trial-in a subgroup of patients with renal failure-that showed reduced heart failure hospitalisation by 42% for patients managed with pulmonary artery pressure based technology compared to a control group.

Medtronic launches Seeq wearable cardiac monitoring system in USA

Medtronic has announced the US launch of the Seeq Mobile Cardiac Telemetry (MCT) System, an external, wire-free, adhesive heart monitor that can be worn for up to 30 days to help detect and diagnose the cause of irregular heartbeats.

Rivaroxaban may be a safe alternative to standard of care in...

Results from the X-VERT trial have shown that rivaroxaban is a safe and effective alternative to Vitamin K antagonist (VKA) therapy in patients with atrial fibrillation who are undergoing elective cardioversion.

Preventice and eCardio merge as a new holding company

Preventice, developer of the PatientCare Platform and the BodyGuardian Remote Monitoring Sensor and eCardio, a provider of remote cardiac monitoring products and services, have announced a strategic combination to drive innovation and growth in remote monitoring systems and mobile health applications.

Permanent AF doubles risk of stroke compared to paroxysmal AF

Permanent atrial fibrillation (AF) doubles the risk of stroke compared to paroxysmal AF, according to research in more than 6,000 patients presented at European Society of Cardiology Congress. The findings suggest that a simple clinical assessment of the type of AF can help doctors to better estimate stroke risk.

Sudden death predictor identifies ICD candidates in new ESC Guidelines

A new sudden death predictor for patients with hypertrophic cardiomyopathy identifies candidates for implantable cardioverter defibrillators (ICDs) in ESC Guidelines published recently. They were presented at the European Society of Cardiology (ESC) Congress by Task Force chairperson Perry Elliott (The Heart Hospital, London, UK).

Remote monitoring costs in ICD patients comparable to in-office monitoring

Results from the EuroEco trial have found that the cost of remote monitoring (with Biotronik Home Monitoring) of patients with implantable cardioverter defibrillators (ICDs)-to physicians, hospitals and insurance providers-does not differ significantly from traditional in-office monitoring.

Favourable effect of Pradaxa on kidney function over time compared to...

New data indicate that kidney function decline is less pronounced in patients with non-valvular atrial fibrillation who are treated with Pradaxa (dabigatran etexilate) compared to warfarin.

FDA clears Vdrive with V-Loop system

Stereotaxis has announced that it has received 510(k) clearance by the Food and Drug Administration (FDA) to market its Vdrive robotic navigation system with V-Loop variable loop catheter manipulator in the USA.

New drug LCZ696 superior to enalapril in heart failure treatment

Findings from the PARADIGM-HF trial have found that the investigational medicine LCZ696 (Novartis) cuts cardiovascular deaths by 20% compared to ACE inhibitor enalapril in heart failure patients with reduced ejection fraction.

Experience in clinical practice and expanding research programme support use of...

During this final phase of the registry programme, data on the overall safety and effectiveness of antithrombotic treatments will be collected.

IN-TIME trial confirms 50% reduction in mortality in HF patients

The IN-TIME trial, which was recently published in The Lancet, demonstrated that heart failure patients' mortality can be reduced by more than 50% using Biotronik Home Monitoring.

Large-scale study confirms growing body of clinical evidence for St Jude...

St Jude Medical has announced results from a large-scale, clinical study concluding that the Quartet left-ventricular quadripolar lead provides more options to effectively manage common pacing complications compared to systems with bipolar leads.

Treating cardiac patients who have sleep apnoea with positive airway pressure...

Results from an analysis of the German Statutory Insurance database showed that the three-year mortality of people with sleep apnoea was significantly lower in patients who were treated with positive airway pressure devices compared to a similar cohort who were not.

BioControl Medical crosses enrolment milestone in INOVATE-HF study

BioControl Medical has announced that it has reached 480 randomised patients - or 70% - of the planned 650 subjects with congestive heart failure in the INOVATE-HF trial of its CardioFit system.

SMART-AF trial shows AF ablation with contact force sensing catheter is...

Results from the SMART-AF trial, recently published in the Journal of the American College of Cardiology, have shown that the ThermoCool SmartTouch contact force-sensing catheter is safe and effective for the treatment of drug-refractory symptomatic paroxysmal atrial fibrillation.

First implants in largest-ever global trial of cardiac resynchronisation therapy

Medtronic has announced the first implants in a clinical trial that will compare patient and healthcare system outcomes in heart failure patients who have cardiac resynchronisation therapy (CRT) devices with the AdaptivCRT feature enabled versus patients receiving standard CRT.

Joint consensus on antithrombotic use in AF patients with acute coronary...

A new European joint consensus document on the use of antithrombotic drugs in patients with atrial fibrillation presenting with an acute coronary syndrome and undergoing percutaneous coronary intervention has been published in the European Heart Journal.

FDA clears CorMatrix CanGaroo ECM envelope

CorMatrix Cardiovascular has announced that it has FDA clearance to market the CorMatrix CanGaroo ECM envelope for use with cardiac implantable electronic devices, including pacemakers and implantable cardioverter defibrillators (ICD's).

Medtronic Viva CRT-P gets FDA approval

Medtronic has announced the US Food and Drug Administration (FDA) approval of its newest cardiac resynchronisation therapy-pacemaker, Viva CRT-P, for indicated patients with heart failure or atrioventricular block.

Study finds nMARQ ablation catheter fast and effective for the treatment...

A recent feasibility study has found irrigated multi-electrode radiofrequency ablation of atrial fibrillation using the novel 10-pole circular, open-irrigated mapping and ablation catheter nMARQ device (Biosense Webster) to be fast and effective.

AliveCor receives first FDA clearance to detect a serious heart condition...

AliveCor has announced that the US Food and Drug Administration (FDA) has granted the company clearance for its algorithm to detect atrial fibrillation.

Bristol-Myers Squibb and Pfizer to present new Eliquis (apixaban) data at...

Bristol-Myers Squibb Company and Pfizer have announced that they will present 14 abstracts (oral and poster presentations) at the ESC Congress 2014, 30 August to 4 September in Barcelona, Spain.

John Muir Health’s Concord medical centre one of 20 hospitals in...

John Muir Health's Concord medical centre is one of just 20 hospitals in the USA to begin treating patients who suffer from atrial fibrillation with a new procedure that features the FDA-cleared FIRMap catheter.

Impulse Dynamics announces first implantation of the Optimizer IVs device in...

Impulse Dynamics has announced the first implantation of the Optimizer IVs device in the Czech Republic earlier this summer. The implantation took place at the Na Homolce Hospital in Prague (Czech Republic) by Petr Neuzil, head of Cardiology at the same institution.

Exercise may protect older women from atrial fibrillation

Increasing the amount or intensity of physical activity can cut the chances of older women developing atrial fibrillation, according to new research in the Journal of the American Heart Association (JAHA).

Hansen Medical announces exclusive distribution with Adachi

Hansen Medical and Adachi have announced a distribution agreement for Magellan and Sensei Robotic Systems in Japan. As part of the distribution agreement, Adachi is responsible for obtaining Japanese Marketing approval from the Pharmaceuticals and Medical Devices Agency for the systems.

PARADIGM-HF trial results of LCZ696 for heart failure to be presented...

New data revealing the reduction in cardiovascular deaths with Novartis' LCZ696 in patients with heart failure with reduced ejection fraction will be presented at the European Society of Cardiology (ESC) Congress 2014.

IN-TIME trial results on remote monitoring published in The Lancet

Biotronik has announced that the IN-TIME study results have been published in The Lancet. The randomised, controlled trial is the first worldwide to demonstrate that automatic, implant-based remote monitoring leads to significant clinical benefits for heart failure patients.

Lariat device shows high rate of acute left atrial appendage closure...

A first US multicentre registry with the Lariat device (SentreHeart) for left atrial appendage ligation has shown 94% acute closure rate; however, procedural success has been limited with major bleeding.

Sports for young patients with implantable cardioverter defibrillators: Refining the risk

Elizabeth Saarel (University of Utah, Salt Lake City, USA) argues that, based on prospective registry data, young patients with implantable cardioverter defibrillators can participate safely in competitive sports.

FDA approves Attain Performa quadripolar lead and Viva Quad CRT-Ds

Medtronic has received US Food and Drug Administration (FDA) approval for the Attain Performa Model 4298 quadripolar lead, and the Viva Quad XT and Viva Quad S cardiac resynchronisation therapy defibrillators (CRT-D).

CardioMEMS system receives approval from CMS for New Technology Add-On Payment

St Jude Medical has announced that the Center for Medicare and Medicaid Services (CMS) has approved a New Technology Add-on Payment (NTAP) for the CardioMEMS heart failure system.

Societies mark 30 years of guidelines for evidence-based cardiovascular care

Marking the 30th anniversary of the publication of their first joint guidelines for the diagnosis and treatment of heart disease, the American College of Cardiology and the American Heart Association have published an extensive review of the process and methodology for evaluating cardiovascular research and writing practice guidelines for clinicians.

Cardiome submits Brinavess reimbursement dossier to Belgian authorities

Cardiome Pharma has announced submission of the Brinavess reimbursement dossier to Belgium's national compulsory health care and benefits insurance authority, The National Institute for Health and Disability Insurance.

The incidence of sudden death in heart transplant patients has not...

A first, large multicentre study in the United States has found that despite the advances in clinical management strategies after heart transplantation, there has not been an improvement in the incidence of sudden cardiac death (SCD) in heart transplant patients over the last three decades.

Is antiarrhythmic gene therapy the future of atrial fibrillation management?

Dierk Thomas (Heidelberg, Germany) writes on the results of preclinical research on antiarrhythmic gene therapy.

Cardioxyl Pharmaceuticals completes first clinical trial for heart failure drug CXL-1427

Cardioxyl Pharmaceuticals has announced the positive results of a clinical trial demonstrating that CXL-1427, a novel potential treatment for acute decompensated heart failure (ADHF), was well tolerated in healthy volunteers.

Running five minutes daily can reduce risk of cardiovascular disease related...

Running for only a few minutes a day or at slow speeds may significantly reduce a person's risk of death from cardiovascular disease compared to someone who does not run, according to a study published in the Journal of the American College of Cardiology.

Cook Medical reintroduces Evolution RL lead extraction products to US market

Effective immediately, Cook Medical customers in the United States will again have access to its Evolution RL and Evolution Shortie RL controlled-rotation dilator sheath sets.

St Jude Medical announces CE mark approval and first use of...

The device has been designed to reduce complications associated with ablation procedures through its ability to bend and conform to the cardiac anatomy, decreasing the amount of pressure distributed to a patient's heart wall while simultaneously increasing the stability of therapy delivery.

Niobe system to be presented at Japan Heart Rhythm meeting

The three-day event is the first large-scale opportunity for the Stereotaxis' in-country distributors to promote the clinical value of the Niobe magnetic navigation system for cardiac ablations to the Japan electrophysiology market.

Moderate alcohol use associated with increased risk for atrial fibrillation

Even in moderation, consumption of wine and hard liquor may be a risk factor for atrial fibrillation, according to new research recently published in the Journal of the American College of Cardiology. The research did not identify a similar risk for moderate consumption of beer.

High self-competence may act as a protective factor against lower quality...

A low sense of self-competence seems to contribute to decreased quality of life for paediatric patients with pacemakers, according to results of a study recently published in the Journal of Developmental & Behavioral Pediatrics.

Physicians implant world’s first ProMRI Quadripolar CRT-D system to treat heart...

With Sentus quadripolar leads and the Inventra series, Biotronik offers the only devices for patients with heart failure worldwide that are approved for MRI use.

What is the best strategy for managing atrial fibrillation?

John D Day, president-elect of the Heart Rhythm Society writes that many cases of atrial fibrillation in the USA could be prevented or reversed with lifestyles focussed on health.

Nick Linker

Nick Linker is president-elect of the British Heart Rhythm Society (BHRS) and programme director of Heart Rhythm Congress (HRC). He tells Cardiac Rhythm News about his leadership in the re-design of the BHRS certification process, his goals for his presidential tenure, the key aspects of running a successful electrophysiology department and the highlights of this year's HRC.

More than five million treated in AHA quality improvement programme

The American Heart Association/American Stroke Association's Get With the Guidelines quality improvement programme reached two milestones this month, touching the lives of more than five million patients, including more than three million people who had strokes.

First US patients undergo full-body MRI scans with Biotronik DX system...

Biotronik has announced that the first device patients to undergo full-body magnetic resonance imaging (MRI) scans in the United States have been implanted with the Biotronik DX system.

New telemedicine solution collects heartbeat data wirelessly

GlobalMed introduces the TotalECG, a battery-powered device that streams 12-Lead data securely and wirelessly to interpretation software on a computer that could be up to 100 feet away.

Boston Scientific welcomes new guidance on the use of cardiac technologies...

In the updated Technology Appraisal, people with ventricular arrhythmias are eligible for an ICD, which can help prevent cardiac arrest in those who have previously survived a life-threatening arrhythmia. In people with heart failure, CRT can improve life expectancy and quality of life.

Dennis, Antman to lead American Heart Association in 2014-15

The American Heart Association has announced its national officers for the 2014-15 fiscal year, which begins July 1.

Study finds Medtronic insertable cardiac monitors detect AF in stroke patients...

The CRYSTAL AF trial found that continuous cardiac monitoring with the Reveal XT insertable cardiac monitor was superior to standard care at detecting atrial fibrillation (AF) in patients who have had strokes of undetermined causes.

Novel oral anticoagulants an option for patients with atrial fibrillation

Offering patients anticoagulants could help prevent thousands of strokes and premature deaths from atrial fibrillation (AF), according to NICE.

ANSWER study shows SafeR algorithm reduces right ventricular pacing and improves...

The ANSWER study evaluated whether the minimisation of Vp using the SafeR algorithm improves clinical outcomes for dual-chamber pacemaker patients implanted for sinus node disease or for atrio-ventricular block.

Wearable defibrillator registry (WEARIT-II) update

At Cardiostim/EHRA Europace (18-21 June, Nice, France), Ilan Goldenberg presented an update on one-year follow-up results from the prospective WEARIT-II registry of 1,404 patients using the Lifevest wearable cardioverter defibrillator (Zoll) who were enrolled in the USA from August 2011 through December 2013.

Defibrillation testing: End of an era, or pause for thought?

The need to perform defibrillation testing at the time of implantable cardioverter defibrillator (ICD) surgery has been the focus of significant discussion and debate over the past years. A number of retrospective studies, prospective series, and recently, the results of the long-awaited randomised SIMPLE trial have further suggested that this may be an unnecessary procedure, Jeanne E Poole writes for Cardiac Rhythm News.

Preliminary positive data for Micra presented at Cardiostim/EHRA Europace

Preliminary results from the first four human procedures with the Micra Transcatheter Pacing System (Medtronic) have shown the device has been successfully implanted with no major complications post-implant.

New study of Pradaxa to explore anticoagulation in ablation of AF...

The RE-CIRCUIT study will investigate the safety and efficacy of uninterrupted anticoagulant treatment with Pradaxa in patients with atrial fibrillation who undergo ablation. Results of the study are expected in 2016.

Nanostim leadless pacemaker receives Cardiostim Innovation Award

The award, which was chosen by a congress committee of electrophysiologists and conveys the support of the electrophysiology community, recognises the Nanostim leadless pacemaker as the industry's most innovative product in the sector of electrophysiology and cardiac techniques.

CRT-D devices with AdaptivCRT associated with reduction of costs of AF

New data from the Medtronic Adaptive CRT trial show a 61% (p=0.01) lower risk of atrial fibrillation (AF)-related problems in patients who receive a cardiac resynchronisation therapy-defibrillator (CRT-D) with the Medtronic-exclusive AdaptivCRT algorithm compared to conventional biventricular pacing therapy.

Schwarzer Cardiotek completes integration

Schwarzer Cardiotek has announced that it has completed the integration of the two companies. For the first time, the company showcased the combined portfolio of the merged entity and introduced its new corporate identity at Cardiostim/EHRA Europace (18-21 June, Nice, France).

NICE no longer recommends aspirin alone for reducing risk of stroke...

Updated National Institute for Health and Care Excellence (NICE) guidelines no longer recommend aspirin use alone, solely to reduce the risk of stroke in patients with atrial fibrillation (AF).

Processed red meat linked to higher risk of heart failure, death...

Men who eat moderate amounts of processed red meat may have an increased risk of incidence and death from heart failure, according to a study in Circulation: Heart Failure, an American Heart Association journal.

Population-based study confirms radiofrequency catheter ablation as safe and effective in...

A new population-based study confirms previous study reports that radiofrequency catheter ablation is a safe method of arrhythmia treatment in children with long-term cumulative efficacy exceeding 90%, and a highly significant decrease in the procedure and fluoroscopy time during the study period.

First Latin American registry of catheter ablation of cardiac arrhythmias

Luis Aguinaga and Roberto Keegan give an overview on the design and initial results of the first Latin American catheter ablation of cardiac arrhythmias registry led by the Latin American Society of Electrophysiology and Cardiac Stimulation (SOLAECE).

Sensei X robotic catheter system to be featured at Cardiostim

The Sensei X2 features faster image processing and a slimmer design with the stability and reachability of its predecessor. The improved processing and imaging capabilities of the Sensei X2 will also be available to users of the current Sensei X upon release.

Stereotaxis submits 510(k) application to FDA for Vdrive with V-CAS

Stereotaxis has announced that it has submitted a 510(k) Premarket Notification to the US Food and Drug Administration (FDA) for the company's Vdrive robotic navigation system with V-CAS catheter advancement system.

Greater surveillance necessary to improve significant public health burden of sudden...

New research in the USA finds that the societal burden of sudden cardiac death is high relative to other major causes of death.

First patient enrolled in Stroke Feasibility Study

The Stroke Feasibility Study is the first US clinical study to evaluate the safety of a novel epicardial-based left atrial appendage closure device for stroke prevention in atrial fibrillation patients.

Preventive placement of ICDs in patients with less severe heart failure...

An examination of the benefit of preventive placement of implantable cardioverter-defibrillators (ICDs) in patients with a less severe level of heart failure finds significantly better survival at three years than that of similar patients with no ICD, according to a study in the June 4 issue of JAMA.

eCardio and Yocaly agree to jointly advance remote cardiac monitoring

eCardio Diagnostics and Shandong Yocaly Information Science & Technology, headquartered in Jinan, China, have recently signed a strategic cooperation agreement focused on furthering the advancement of remote cardiac monitoring products and services in the United States, China and beyond.

CE mark for Advisa and Ensura SR MRI SureScan pacemaker systems

Medtronic has announced CE mark approval and commercial launch of the Advisa and Ensura SR MRI SureScan single-chamber pacemaker devices in Europe. Both pacemakers are approved for magnetic resonance imaging (MRI) scans positioned on any region of the body.

EPIC Alliance questions sports ban for young ICD patients

In her presentation at the German Cardiac Society's annual conference, Karin Nentwich (Bad Neustadt, Germany) concluded that implantable defibrillators are not contraindicated for young people engaging in physical education, sports and-within limits-competitive sports.

FDA approves CardioMEMS heart failure system

The US Food and Drug Administration has approved the CardioMEMS heart failure system that measures the pulmonary artery pressures and heart rates of patients with New York Heart Association (NYHA) Class III heart failure who have been hospitalised for heart failure in the previous year. The device allows health care professionals to monitor the condition of their patients remotely.

Free heart checks available in more than 100 pharmacies in North...

AliveCor has announced that in partnership with more than 100 pharmacies across North East London, free heart checks are being offered as part of Heart Rhythm Week, an international campaign from 2-6 June 2014. Participating pharmacies can screen for AF using the AliveCor heart monitor. Blood pressure screenings are also being offered to screen for hypertension.

St Jude Medical completes acquisition of CardioMEMS

St Jude Medical has announced it has completed its acquisition of privately held CardioMEMS, developer of the CardioMEMS heart failure system. The acquisition was completed on 30 May 2014.

Spectranetics receives CE mark for TightRail rotating dilator sheath platform

Spectranetics has announced receiving CE mark approval for its TightRail Rotating dilator sheath platform for mechanical cardiac lead extraction procedures.

Biotronik’s defibrillators for 3.0 Tesla and full-body MRI get CE mark...

Biotronik has announced receiving CE mark approval for its ProMRI technology for ultra high field 3.0 tesla (T) and full-body magnetic resonance imaging (MRI) with the standard 1.5 T scan strength.

Antidote for rapid reversal of dabigatran progresses into next stage of...

Boehringer Ingelheim has announced the next step in the clinical development of idarucizumab, the investigational antidote for rapid reversal of dabigatran-induced anticoagulation

iRhythm secures US$17 million in funding led by Novo A/S as...

iRhythm, has announced that it closed a US$17 million Series E financing led by Novo A/S. Norwest Venture Partners, which led the company's Series D financing, also participated in the oversubscribed round

IN-TIME shows equal benefit of home telemonitoring in ICD and CRT-D...

Home telemonitoring is equally effective in ICD and CRT-D patients, a subanalysis of the IN-TIME trial has shown.

Hospital visits for atrial fibrillation rising

An 11-year study shows that hospitalisations for atrial fibrillation jumped by 23% and costs rose by 24%. The rise in atrial fibrillation's accompanying risk factors might account in part for the rise in hospitalisations.

New data show that defibrillators programmed to wait longer to deliver...

Medtronic has announced the results from the first prospective randomised clinical trial to show that Medtronic implantable cardioverter defibrillators (ICDs) can safely extend detection times before triggering therapy in secondary prevention patients.

New expert consensus statement attempts to close the gap on guidance...

The expert consensus statement provides first-of-its-kind guidance on ICD therapy for the management of patient populations who are not well represented in clinical trials and, as a result, not specifically included in existing guidelines.

Study of Latitude remote patient management system demonstrates significant reduction in...

Patients using the Boston Scientific Latitude remote patient management system with wireless telemetry demonstrated significantly lower mortality and fewer hospitalisations than patients with Latitude-compatible devices who were not followed on the system, according to results from the PREDICt-RM study (Patient related determinants of ICD remote monitoring utilisation and outcomes).

MINERVA shows delays of persistent atrial fibrillation progression with advanced pacing...

Results from the MINERVA (Minimize right ventricular pacing to prevent atrial fibrillation and heart failure) study have found that the Reactive ATP algorithm from Medtronic reduced the development of persistent atrial fibrillation by a 58% relative reduction compared to standard pacemakers (p<0.001).

FDA approves Biotronik Entovis pacemaker system with ProMRI technology

The Entovis system allows patients to undergo Magneti