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 has received CE mark approval for its AcQMap high resolution imaging and mapping system, and for its AcQMap catheter.
Cell Therapy has granted the Japan license for its innovative cardiac regeneration medicine, Heartcel (immuno-modulatory progenitor (iMP) cells) to Daiichi Sankyo.
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.
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.
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.
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).
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 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.
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 (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 Systems has officially launch its Interventional cardiac resynchronisation therapy initiative during the Heart Rhythm Society (HRS) Meeting in San Francisco, USA.
The Iperia ProMRI HF-T cardiac resynchronisation defibrillator has been approved by the US Food and Drug Administration (FDA).
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.
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).
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 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.
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 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 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 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 has announced Food and Drug Administration (FDA) approval of BioMonitor 2, an insertable cardiac remote monitor with ProMRI technology.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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 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.
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.
St Jude Medical has announced the launch and CE mark approval for three new Quartet left ventricular (LV) leads.
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.
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).
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 has been announced as the next medical director of the British Heart Foundation. He will succeed Peter Weissberg who will retire in October 2016.
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 has introduced the first medical-grade Electrocardiogram (EKG) band for the Apple Watch, the Kardia Band, along with a new app for smartphones.
InfoBionic has received 510(k) clearance from the US Food and Drug Administration (FDA) for MoMe Kardia, a wireless, remote monitoring system.
Arca Biopharma has announced the GENETIC-AF trial, which will evaluate bucindolol (Gencaro) as a potential treatment for atrial fibrillation.
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.
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%.
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.
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 (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 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.
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.
The first commercial implantations of WiSE (wireless stimulation endocardially) technology (EBR Systems) have taken place in the UK and Czech Republic.
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.
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 has opened the Education and Innovation Center in New York, USA to hold educational programmes.
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.
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.
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.
The panel provided insight around patient selection and post approval study methodology, folowing a panel discussion on leadless pacing technology.
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.
This technology is designed to provide additional options which may benefit cardiac resynchronisation therapy patients who are not responsive to other methods of pacing.
The first patient has been enrolled in the ATLAS (AtriClip Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures) clinical study.
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.
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.
The company will concentrate on developing new technologies to aid in the advancement of cardiovascular medicines using stem cell therapy.
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.
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.
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.
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.
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.
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 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.
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.
Kalila Medical has a novel steerable sheath that is designed to help physicians more easily access and perform catheter-based electrophysiology procedures.
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.
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.
This trial evaluates bucindolol hydrochloride (Gencaro) as a potential genetically-targeted treatment for the prevention of atrial fibrillation.
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.
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.
The German Federal Joint Committee (Gemeinsamer Bundesausschuss-G-BA) has granted Daiichi Sankyo's edoxaban (Lixiana) an indication of a minor additional benefit.
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 (Entresto, Novartis) has been made available in the UK for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction.
The Advantage-MR EP recorder/stimulator system is a magnetic resonance conditional recording system for magnetic resonance imaging-guided electrophysiology procedures.
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.
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.
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.
The recently-obtained data demonstrates continuing and steady progress for the drug candidates in Verseon's anticoagulation program, according to a press release.
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.
Mark W Kroll (Minneapolis, USA) writes about the importance of optimisation of implantable cardioverter defibrillators (ICDs) in the absence of defibrillation threshold testing.
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).
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 has been granted US Food and Drug Administration approval for use of a group of implantable cardioverter defibrillator systems with magnetic resonance imaging scans.
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 has acquired FlexLife Health, a company which offers patients remote services to monitor and measure coagulation.
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
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.
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.
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.
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.
BIOSync CLS will investigate the efficacy of the uniquely physiologic rate response sensor CLS in preventing syncope.
HeartRescue is a Medtronic Philanthropy partnership launched in five US states in 2010, which aims to improve Sudden Cardiac Arrest (SCA) survival rates.
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.
The device from Spectranetics is designed to substantially reduce blood loss in the event of a superior vena cava tear.
Biotronik is to support its charity partner, Heartbeat International (HBI) at the 25th Interamerican Congress of Cardiology, in Santiago, Chile.
Cardiac resynchronisation therapy with defibrillator may prevent hospitalisation due to heart failure, when compared to treatment with implantable cardioverter defibrillator alone.
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.
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 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.
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.
This trial aims to determine if closed loop stimulation can delay the onset of atrial fibrillation and reduce the risk of stroke.
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.
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.
A study has shown heart failure, diabetes and recent heart attacks to be the strongest predictors of stroke caused by a blocked artery.
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 (sacubitril/valsartan) has been authorised for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).
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.
This award recognises Ebit's Suitestensa cardiovascular information system (CVIS) integration platform.
This acquisition adds the Coherex WaveCrest left atrial appendage (LAA) occlusion system to BioSense's portfolio.
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.
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.
According to Medtronic, this is the world's first app-based remote monitoring system for patients with implantable pacemakers.
The new device is a subcutaneous, insertable cardiac remote monitor designed to continuously monitor cardiac electrical events reliably and accurately.
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.
Vic Gundotra has worked as a senior vice president at Google, after spending 15 years with Microsoft.
The transcatheter pacing system from Medtronic is the smallest pacemaker on the market.
Concerns for both patients and their partners declined after three months.
The symposium is an educational program for electrophysiologists and device-oriented cardiologists.
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.
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
Platinum is designed to protect patients from avoidable replacement surgeries and the inherent risk of complications.
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
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 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.
The Visia AF and Visia AF MRI SureScan are designed to detect and monitor new onset, asymptomatic and previously undiagnosed atrial fibrillation.
Idarucizumab (Praxbind) is the first reversal agent approved specifically for dabigatran and works by binding to the drug compound to neutralise its effect.
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 (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 (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
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 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 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.
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 has entered into a definitive merger agreement under which it will acquire nContact, a privately-held developer of innovative cardiac ablation solutions.
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 has announced the launch of the Cryoform cryoablation probe, which offers increased probe flexibility to adapt to a variety of surgical ablation procedures.
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.
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.
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.
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).
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.
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.
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.
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.
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.
The second part of Portola Pharmaceuticals' phase 3 ANNEXATM-R study achieved all primary and secondary endpoints with high statistical significance.
Financial details of the transaction are not being released. The combination creates one of the world's largest AED solutions providers.
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.
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.
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.
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.
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 (sacubitril valsartan) will be made available to eligible patients in the UK before a final European licensing decision is made.
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.
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.
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.
First-of-its-kind findings from two independent studies have identified a gene associated with sudden cardiac death.
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.
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.
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.
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.
Study reveals how physical exertion may trigger sudden death in people with apparently healthy hearts.
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.
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 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 has announced CE mark approval and the results of a pilot study into the performance of the subcutaneous, insertable cardiac monitor BioMonitor 2.
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.
This revised labelling ensures that future patients and those already implanted with these systems are able to undergo MRI scans if indicated.
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.
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.
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.
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.
A new study shows that walking and cycling for 20 minutes per day has greatest impact on lowering the risk of heart failure.
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.
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 Final Appraisal Determination recommends that edoxaban is a cost-effective use of NHS resources.
Study evaluates whether early detection of cardiac arrhythmias by BioMonitor with home monitoring reduces major cardiovascular events in post-acute myocardial infarction patients.
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.
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 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).
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.
A press release states that the company is now the only one offering both implantable cardioverter-defibrillators (ICDs) and pacemakers approved for 3T scans.
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.
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.
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 more likely to experience sudden cardiac arrest and at a much earlier age than their white compatriots, according to research published in Circulation.
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.
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.
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.
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.
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.
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.
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.
New study published in HeartRhythm shows differences in the utilisation of atrial fibrillation therapies in a large nationwide population.
First patient enrolled in global clinical investigation into differences in gender response to cardiac resynchronisation therapy.
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.
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.
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.
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.
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.
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.
The reduction in blood loss correlated with reversal of the anticoagulant effects of rivaroxaban as measured by anti-Factor Xa activity.
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 (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.
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 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.
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 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.
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.
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).
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.
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.
CardioInsight Technologies will now become part of the Medtronic Atrial Fibrillation Solutions business in the Cardiac Rhythm and Heart Failure division.
The Confidense module's proprietary algorithm streamlines data collection, annotation and validation for the market-leading Carto system.
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.
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.
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.
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.
Eighty AED Plus units will be distributed among the mobile medical teams and be available across all Baku 2015 venues.
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.
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 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.
Long-term Citadel/Centurion clinical trial findings and independent data presented at Heart Rhythm Society 36th Annual Scientific Sessions.
The third-generation cryoballoon is designed to allow enhanced positioning and help improve capture of real-time data with achieve mapping catheter.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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 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.
RIO 2 study evaluates safety and effectiveness of moving the insertion procedure from hospital to office setting.
A first-in-human study shows low level transcutaneous electrical vagus nerve stimulation, a completely non-invasive approach, suppresses paroxysmal atrial fibrillation.
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.
New device allows for earlier therapy adjustments in heart patients with pacemakers, implantable cardioverter-defibrillators, cardiac resynchronisation therapy and BioMonitor devices.
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.
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.
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.
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.
For the first time, the American Heart Association has issued recommendations for healthcare providers treating people older than 40 with congenital heart disease.
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.
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%).
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.
Data support registration of Andexanet Alfa Bolus-Only and Bolus-Plus-Continuous-Infusion dosing regimens to reverse anticoagulant effect of Factor Xa Inhibitors.
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.
Investigators report data from first cohort in destination therapy at the 35th annual International Society for Heart and Lung Transplantation Meeting in Nice, France.
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.
The study, published in JACC: Clinical Electrophysiology, found that the benefits of participation may outweigh risks for children with heart conditions.
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.
Fellowship provides newly-graduated cardiothoracic surgeons with a unique opportunity to be trained by nationally recognised experts in atrial fibrillation surgery.
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.
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.
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.
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 has announced that the first US patient has been implanted with the company's Eluna pacemaker system with ProMRI technology.
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.
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.
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.
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.
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 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
The GENETIC-AF phase 2B/3 clinical trial is evaluating Gencaro (bucindolol hydrochloride) as a potential treatment for atrial fibrillation.
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.
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.
First phase II data demonstrating anticoagulant prescribing patterns in North America now available from GLORIA-AF Registry programme.
Cleveland Heart International to acquire majority interest in Korean automatic external defibrillators manufacturer CU Medical.
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).
This latest version defines cardiology core competencies for the first time.
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 multicentre study of the miniaturised implantable cardiac monitor Reveal Linq (Medtronic) suggests the device is safe and provides adequate sensing capabilities to detect arrhythmias.
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.
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-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.
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.
Analysis of 19 studies finds atrial fibrillation patients taking digoxin are 27% more likely to die than those who do not.
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.
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 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.
Sorin and Cyberonics have announced their merger plan with a combined equity value of approximately US$2.7bn (€2.4bn).
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 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 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.
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.
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.
The Stronger Hearts Helpline pilot programme centralises resources to educate and improve access to care.
With the launch, the hospital becomes the first in Europe to operate two Niobe systems for clinical procedures.
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.
Studies validate safety of Biotronik ProMRI devices in patients subjected to head and lower lumbar 1.5T MRI scans.
New data demonstrate cost-effectiveness of long-term, continuous cardiac monitoring with potential to prevent recurrent strokes.
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.
The Vanguard (Vagal nerve stimulation safeguarding heart failure patients) clinical study evaluates Equilia, a neurostimulation system for heart failure patients.
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.
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.
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
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.
Andexanet alfa is the only universal factor Xa inhibitor antidote shown to directly reverse the anticoagulant activity of these agents in clinical studies.
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.
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 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.
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.
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.
In addition, Xarelto (rivaroxaban) label now includes guidance for use in patients with atrial fibrillation undergoing cardioversion.
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.
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.
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.
The ProMRI study consists of a series of MRI compatibility trials intended to increase cardiac device patients' access to MRI.
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.
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.
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.
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.
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 has acquired all outstanding equity of Topera for US$250m upfront, plus potential future payments tied to performance milestones.
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 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 secures nationwide Department for Education tender to provide schools with the latest HeartStart FRx automated external defibrillators.
Analysis of Biotronik-sponsored REPLACE registry identifies key patient risk factors and reveals comorbidities more relevant than procedure-related complications.
George H Crossley (Nashville, USA) writes on the role of quadripolar leads in cardiac resynchronisation therapy to treat heart failure patients.
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.
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.
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.
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.
The newest additions to the Attain Performa lead portfolio are designed to accommodate patients' varying vessel sizes and curvatures to enhance successful lead placement.
Phase B of Biotronik's ProMRI study has completed patient enrolment and concluded all planned scans.
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 has secured a CE mark for the ZIO Service, enabling the company to market its long-term continuous heart monitoring solution in Europe.
Biotronik has launched its new series of single- and dual-chamber implantable cardioverter defibrillators and cardiac resynchronisation therapy defibrillators.
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.
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.
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.
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.
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 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).
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.
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).
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.
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 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 has partnered with advocacy organisation StopAfib.org to encourage Americans to "Get SMART About Afib."
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
Daiichi Sankyo has announced that the FDA has recommended approval of once-daily Savaysa (edoxaban) 60mg dosing regimen.
Hansen Medical's Sensei X2 robotic system is now commercially available in the USA and European Union.
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 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.
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 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.
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.
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 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 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).
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 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 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.
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.
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 has announced the first 10 heart failure patients treated with the Barostim neo system under CE mark approval.
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.
The American College of Cardiology, along with eight partnering societies, have released the first appropriate use criteria for suspected heart disease in paediatric patients.
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 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 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.
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.
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.
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 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.
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, 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 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.
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).
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.
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.
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.
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.
During this final phase of the registry programme, data on the overall safety and effectiveness of antithrombotic treatments will be collected.
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.
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.
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 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.
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.
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.
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.
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 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.
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 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 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 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 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.
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 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.
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.
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.
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.
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.
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).
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.
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 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.
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.
Dierk Thomas (Heidelberg, Germany) writes on the results of preclinical research on antiarrhythmic gene therapy.
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 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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
The American Heart Association has announced its national officers for the 2014-15 fiscal year, which begins July 1.
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.
Offering patients anticoagulants could help prevent thousands of strokes and premature deaths from atrial fibrillation (AF), according to NICE.
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.
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.
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 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.
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.
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.
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 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).
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).
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.
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.
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).
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 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.
New research in the USA finds that the societal burden of sudden cardiac death is high relative to other major causes of death.
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.
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 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.
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.
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.
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.
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 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 has announced receiving CE mark approval for its TightRail Rotating dilator sheath platform for mechanical cardiac lead extraction procedures.
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.
Boehringer Ingelheim has announced the next step in the clinical development of idarucizumab, the investigational antidote for rapid reversal of dabigatran-induced anticoagulation
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
Home telemonitoring is equally effective in ICD and CRT-D patients, a subanalysis of the IN-TIME trial has shown.
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.
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.
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.
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).
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).
The Entovis system allows patients to undergo Magnetic Resonance Imaging (MRI) scans with a limited exclusion zone. FDA approval covers both single chamber (SR-T) and dual chamber (DR-T) Entovis pacemakers when implanted with Setrox pacing leads.