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Boston Scientific’s POLARx FIT cryoablation system gains CE mark
Boston Scientific has received CE mark for its POLARx FIT cryoballoon catheter for atrial fibrillation (AF) ablation.
According to the company, the device is the...
Boston Scientific partners with Telefónica España to enhance remote support capabilities
Boston Scientific is collaborating with Telefónica España to provide ‘advanced healthcare technology’, including 5G, through its recently launched Remote Clinical Support Centre—RhythmCARE—which is intended...
Boston Scientific closes acquisition of Baylis Medical Company
Boston Scientific has announced the close of its acquisition of Baylis Medical Company, a company that offers advanced transseptal access solutions as well as...
Baylis Medical Company to sell its cardiology business to Boston Scientific
Baylis Medical Company has reached an agreement to sell its cardiology business to Boston Scientific.
The acquisition, for an upfront payment of US$1.75 billion, subject...
Boston Scientific to acquire Preventice Solutions
Boston Scientific has entered into a definitive agreement to acquire Preventice Solutions, a privately-held company which offers a full portfolio of mobile cardiac health...
Boston Scientific initiates CHAMPION-AF trial of Watchman FLX
Boston Scientific has initiated the CHAMPION-AF clinical trial to evaluate the safety and efficacy of the Watchman FLX left atrial appendage closure (LAAC) device...
Boston Scientific to invest in pulsed field ablation device developer
Boston Scientific has signed an investment agreement with an exclusive option to acquire Farapulse, a privately-held company developing a pulsed field ablation (PFA) system...
Boston Scientific gets FDA 510(k) clearance for Lux-Dx ICM
Boston Scientific has received US Food and Drug Administration (FDA) 510(k) clearance for the Lux-Dx insertable cardiac monitor (ICM) system, a new, long-term diagnostic...
Boston Scientific launches its DirectSense technology in the USA
Boston Scientific has announced the US launch of DirectSense technology, a tool for monitoring the effect of radiofrequency (RF) energy delivery during cardiac ablation...
Boston Scientific announces positive PINNACLE FLX study results
Boston Scientific has announced positive 12-month results from the PINNACLE FLX clinical trial assessing the safety and efficacy of the next-generation WATCHMAN FLX Left...
Boston Scientific initiates trial comparing left atrial appendage closure to direct oral anticoagulants for...
According to a press release, Boston Scientific has initiated the OPTION trial to compare safety and effectiveness of the next-generation Watchman FLX left atrial...
Boston Scientific to buy cerebral protection system company
Boston Scientific has signed an agreement to acquire Claret Medical, which developed and commercialised the Sentinel cerebral embolic protection system. The device is used...
Boston Scientific to acquire Cryterion Medical
As part of its plan to expand it atrial fibrillation ablation therapy offering, Boston Scientific Corporation has announced a definitive agreement to acquire Cryterion...
Boston Scientific launches the HeartLogic heart failure diagnostic in Europe
Boston Scientific Europe has announced the launch of the HeartLogic Heart Failure Diagnostic in Europe. With this launch, the first and only diagnostic tool...
Boston Scientific announces acquisition of Securus Medical Group
Boston Scientific have announced the acquisition of Securus Medical Group, a privately-held company that has developed a thermal monitoring system for the continuous measurement...
Boston Scientific announces investment and acquisition option agreement with Millipede, Inc.
Boston Scientific Corporation today announced it has closed an investment and entered into an acquisition option agreement with Millipede, Inc., a privately-held company that has developed...
TCT 2017: Boston Scientific reveals presentations at conference
Boston Scientific has announced key data will be presented at next week’s Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Denver, USA). For example,...
Boston Scientific announces agreement to acquire Apama Medical
Boston Scientific Corporation has announced a definitive agreement to acquire Apama Medical, a privately-held company that is developing the Apama Radiofrequency (RF) Balloon Catheter...
Boston Scientific gets FDA approval for MRI labelling and launches Resonate devices in the...
Boston Scientific has launched the Resonate family of implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) systems featuring the HeartLogic Heart Failure...
Boston Scientific receives US FDA approval for Resonate family of high-voltage devices
The US Food and Drug Administration (FDA) has approved Boston Scientific’s Resonate family of implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D)...
Boston Scientific announces scheduled presentations at Heart Rhythm Society 2017
Boston Scientific has announced the schedule of key data presentations, including two late-breaking clinical trials that will be featured at the Heart Rhythm Society’s...
UK NICE recommends Boston Scientific CRT-D devices using EnduraLife battery technology
The National Institute for Health and Care Excellence (NICE) has issued medical technology guidance recommending the use of Boston Scientific’s cardiac resynchronisation therapy defibrillators...
Boston Scientific launches Resonate CRT-D platform in Europe
Boston Scientific has launched the Resonate cardiac resynchronisation therapy defibrillator (CRT-D) systems in Europe. This new family of devices features SmartCRT technology, which recently...
US FDA approves Boston Scientific Emblem MRI S-ICD system
Boston Scientific has received US Food and Drug Administration (FDA) approval for the Emblem MRI subcutaneous implantable defibrillator (S-ICD) system, as well as magnetic...
EFFORTLESS long-term study confirms safety and efficacy of Boston Scientific Subcutaneous Implantable Defibrillator
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.
FDA approves Boston Scientific navigation-enabled IntellaNav catheters
Boston Scientific has received US Food and Drug Administration (FDA) approval for two catheters that can be used with the company's Rhythmia mapping system.
Boston Scientific announces Heart Rhythm Society 2016 presentations
Boston Scientific has announced key data, including one late-breaking clinical trial, that will be featured at the 37th Annual Scientific Sessions of the Heart Rhythm Society (HRS) in San Francisco on May 4-7 2016.
Boston Scientific receives CE mark for MRI labelling of Emblem S-ICD system
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.
Boston Scientific is suspending sales of Watchman FLX in Europe
According to a Reuters news report, Boston Scientific is temporarily suspending sales of Watchman FLX—the next-generation of its left atrial appendage closure device, Watchman....
Boston Scientific receives FDA approval for Blazer open-irrigated catheter
The approval of the Blazer OI catheter marks the first time Boston Scientific will offer an open-irrigated catheter to the US market.
Boston Scientific receives FDA approval for Acuity X4 quadripolar leads
The US Food and Drug Administration has granted approval to Boston Scientific for its Acuity X4 quadripolar left ventricular leads. The company can now offer its first full X4 cardiac resynchronisation system to the US market.
US Medicare to cover Boston Scientific Watchman left atrial appendage closure device
The US Centers for Medicare and Medicaid Services (CMS) are to cover percutaneous left atrial appendage closure (LAAC) therapy under specific criteria, as outlined...
Boston Scientific and Accenture develop data-driven digital health platform to improve efficiency and patient...
Boston Scientific and Accenture are to launch a cloud-based, data-driven healthcare system for hospitals. The system, called Advantics Care Pathway Transformation, is designed to...
Boston Scientific announces CE mark for MRI compatible labelling for ICD and CRT-D systems
This revised labelling ensures that future patients and those already implanted with these systems are able to undergo MRI scans if indicated.
Boston Scientific to become significant shareholder in Preventice Solutions
Boston Scientific is also to become the exclusive global sales and marketing representative for the company's cardiology-related offerings.
Boston Scientific initiates study to assess Emblem S-ICD in primary prevention patients with low...
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.
Long-term data show safety and efficacy of Boston Scientific’s S-ICD System
The S-ICD System was shown to convert more than 98% of heart arrhythmias that can lead to sudden death. These data are comparable to efficacy outcomes found in transvenous ICD (TV-ICD) clinical trials (95-99%).
Boston Scientific announces FDA and CE mark approval of the Emblem S-ICD system
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.
Boston Scientific launches long-lasting implantable cardioverter defibrillators
The devices feature EnduraLife battery technology developed with high-performance chemistry and advanced manufacturing capabilities to provide up to double the battery capacity of other defibrillators.
Boston Scientific receives CE mark approval for MRI compatible Accolade pacemakers and new CRT-Ps
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.
Boston Scientific welcomes new guidance on the use of cardiac technologies for patients with...
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.
Boston Scientific joins Optum Labs as Founding Medical Device Partner
Boston Scientific Corporation has joined Optum Labs as the Founding Medical Device Partner to help pioneer new research into effective treatments for heart failure and related cardiac conditions.
Boston Scientific begins NAVIGATE X4 clinical trial
Boston Scientific has announced that it has conducted the first implant in the NAVIGATE X4 clinical trial of the next generation Acuity X4 left-ventricular (LV) pacing leads and Reliance 4-Front defibrillation (ICD) leads.
Boston Scientific announces FDA approval of new defibrillators and heart failure devices
Boston Scientific has received FDA approval for its latest generation of defibrillators and heart failure devices. The newly approved devices include the Dynagen Mini and Inogen Mini ICDs, as well as the Dynagen X4 and Inogen X4 CRT-Ds.
Boston Scientific begins expansion of S-ICD system in Asia
Boston Scientific Corporation has expanded the launch of its S-ICD system into parts of Asia. The first implant of the S-ICD system in Asia was performed in Hong Kong by Hung Fat Tse, professor of cardiovascular medicine, The University of Hong Kong and Department of Medicine, Queen Mary Hospital in Pokfulam, Hong Kong, under the proctorship of Martin Stiles, director of Electrophysiology, Waikato Hospital in Hamilton, New Zealand.
New data illustrate long-term safety and effectiveness of Boston Scientific S-ICD system
The interim analysis of the ongoing EFFORTLESS S-ICD registry, which evaluated 456 patients with a mean follow-up of 558 days, is the first real-world study to date and confirms the clinical benefits of the S-ICD System in a broad range of patients at risk of sudden cardiac arrest.
Long-term data show lower mortality rates in heart failure patients with Boston Scientific CRT...
In the longest follow-up to date of cardiac resynchronisation therapy (CRT) for mild heart failure patients, Boston Scientific's multicentre automatic defibrillator implantation trial - cardiac resynchronisation therapy (MADIT-CRT) study demonstrated significant and sustained survival benefit for the indicated population.
Boston Scientific announces CE mark approval and first implants of Ingevity MRI pacing leads
The Ingevity family offers a comprehensive set of leads that can be placed using a 6 French introducer, including passive and active fixation models. Ingevity MRI pacing leads are part of the ImageReady MR-conditional pacemaker system.
Boston Scientific completes acquisition of Bard Electrophysiology
On 1 November, Boston Scientific closed on its previously announced agreement to acquire Bard EP, the electrophysiology (EP) business of CR Bard.
Boston Scientific opens Institute for Advancing Science and Innovation Center in China
The Institute for Advancing Science will offer training in clinical practice and multidisciplinary programmes in Interventional Cardiology, Cardiac Rhythm Management and Electrophysiology, Endoscopy, Peripheral Interventions and Urology and Women's Health.
Boston Scientific to acquire Bard EP
Boston Scientific has announced that it has entered into a definitive agreement to acquire Bard EP, the electrophysiology business of CR Bard, for US$275 million in cash. The company expects to close the transaction in the second half of 2013, subject to customary closing conditions.
Boston Scientific completes first-in-human clinical trial of the IntellaTip MiFi XP Ablation Catheter for...
A company release states that this new line of ablation catheters is designed to provide physicians with high resolution, precise, multidimensional information through sophisticated micro-sensors at the tip of the catheter.
Boston Scientific begins SAMURAI trial to evaluate new pacing system in MRI environment
The first patient has been implanted with the next generation ImageReady MR Conditional pacing system (Boston Scientific) in the SAMURAI clinical trial.
First patient implanted with the Boston Scientific INGEVITY pacing leads
Boston Scientific is beginning a clinical trial of patients implanted with the INGEVITY device.
Boston Scientific defibrillators receive the CE mark approval for extended longevity
Boston Scientific has received the CE mark approval for increased longevity projections for the Incepta, Energen, Punctua, Cognis and Teligen implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds).
Boston Scientific to acquire Rhythmia Medical
Rhythmia Medical is a developer of next-generation mapping and navigation solutions for use in cardiac catheter ablations and other electrophysiology procedures, including atrial fibrillation and atrial flutter.
Boston Scientific launches new implantable defibrillation lead in Europe and Asia
The Reliance 4-Front lead is designed to streamline surgical procedure for treatment of heart failure and sudden cardiac arrest.
Boston Scientific acquires world’s first subcutaneous ICD
Boston Scientific has added the first and only, commercially available, subcutaneous implantable cardioverter defibrillator technology to its product portfolio
Boston Scientific introduces ICD and CRT-D device warranties of up to 10 years
Boston Scientific has announced extended warranties of up to 10 years, depending on the model, for its Energen and Incepta implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds).
Boston Scientific gets FDA approval for new devices to treat bradycardia
The FDA has approved the Ingenio and Advantio pacemakers and Invive cardiac resynchronisation therapy pacemakers (CRT-P).
Boston Scientific launches Ingenio and Advantio family of pacemakers in Europe
The Ingenio and Advantio pacemakers feature RightRate pacing technology designed to treat chronotropic incompetence.
Boston Scientific to Acquire Cameron Health
Cameron Health is the developer of the world's first and only commercially available subcutaneous implantable cardioverter defibrillator - the S-ICD system.
Boston Scientific begins marketing remote catheter system in Europe through exclusive agreement with Catheter...
The CRI Amigo system, compatible with certain Boston Scientific and other commercially available catheters, lets physicians remotely maneuver diagnostic and ablation catheters designed to treat common cardiac arrhythmias during electrophysiology procedures.
Boston Scientific begins international launch and first implants of next-generation devices to treat heart...
Energen and Punctua cardiac resynchronisation therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs) are the world's smallest and thinnest high-energy devices to treat heart failure and sudden cardiac death and offer excellent longevity.
Boston Scientific to acquire Atritech
The Atritech Watchman left atrial appendage closure device is an alternative to warfarin for patients experiencing atrial fibrillation who are at high risk for stroke.
Boston Scientific announces CE mark approval and first implants for new devices to treat...
Incepta, Energen and Punctua CRT-Ds and ICDs designed to advance patient care with options to expand appropriate therapy, optimise ventricular pacing and manage heart failure.
Boston Scientific announces availability of new connector system designed to simplify the implant procedure...
The company release a new cardiac rhythm management connector system designed to simplify implant procedure.
Boston Scientific to resume distribution of Cognis CRT-Ds and Teligen ICDs in the USA
Boston Scientific has received FDA clearance for the two validated manufacturing changes affecting all of its CRT-Ds and ICDs.
Boston Scientific’s most advanced devices to treat heart failure and sudden cardiac death now...
Cognis cardiac resynchronisation therapy defibrillator and Teligen implantable cardioverter defibrillator are the world's smallest and thinnest high-energy devices.
Boston begins European launch of LUX-Dx insertable cardiac monitor
Boston Scientific has announced the European launch of the LUX-Dx insertable cardiac monitor (ICM) system, a long-term diagnostic device inserted under the skin of...
Medtronic names Laura Mauri as new chief scientific, medical and regulatory officer
Medtronic has announced that Laura Mauri has been appointed as the company’s chief scientific, medical and regulatory officer. This appointment adds to Mauri's prior responsibilities...
Boston expands digital offering with European launch of Heart Connect
Among the array of remote monitoring and digital arrhythmia management tools on display at the 2022 European Heart Rhythm Association annual meeting (EHRA 2022,...
Boston acquires remaining shares of Farapulse
Boston Scientific has exercised its option to acquire the remaining shares of Farapulse. The acquisition will complement the existing Boston Scientific electrophysiology portfolio to...
Douglas Drachman named as next vice chair of American College of Cardiology’s Annual Scientific...
Douglas Drachman has been selected as the next vice chair of the American College of Cardiology’s Annual Scientific Session. Drachman will serve as vice...
Rhythmview system featured at Boston Atrial Fibrillation Symposium 2012
Rhythmview (Topera Medical) is a mapping system that helps identify the electrical source of cardiac arrhythmias. It will be utilised as part of a complex procedure demonstration on 12 January at the 17th Annual Boston Atrial Fibrillation Symposium.
Watchman presents possible alternative to warfarin for stroke prevention in patients with atrial fibrillation
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.
S-ICD system receives favourable US coding and payment designations for 2015
Boston Scientific has announced that its subcutaneous implantable defibrillator (S-ICD System) will have designated Current Procedural Terminology (CPT) Category I codes by the American Medical Association, effective 1 January 2015.
FDA’s Advisory Committee Panel votes in favour of Watchman device
Members of the US Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee have voted in favour of the Watchman left atrial appendage closure (LAAC) device (Boston Scientific), by a close vote of 6 to 5 (with 1 abstention) concluding that the potential benefits of Watchman outweigh the potential risks. The Panel also voted unanimously in favour of the device safety; however, its effectiveness saw unfavourable voting.
Study of Latitude remote patient management system demonstrates significant reduction in mortality and hospitalisation
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).
Subcutaneous ICD continues to show positive results in a real-world scenario
Updated results of the EFFORTLESS S-ICD registry have shown the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD, Boston Scientific) continues to show effective conversion of induced and ambulatory ventricular tachycardia or fibrillation (VT/VF) comparable to standard ICD performance and low complication rates.
Next-generation X4 quadripolar CRT-D systems are CE-marked
Boston Scientific has announced it has received CE mark approval of its X4 line of quadripolar CRT-D systems including Autogen X4, Dynagen X4, and Inogen X4 cardiac resynchronisation therapy defibrillators (CRT-Ds), a suite of Acuity X4 quadripolar left ventricular (LV) leads and the Acuity Pro lead delivery system.
New trial shows subcutaneous implantable cardioverter defibrillator is safe and effective
A new trial has found that the subcutaneous implantable cardioverter defibrillator (S-ICD System, Cameron Health/Boston Scientific) is safe and effective at detecting and treating both induced and spontaneous ventricular tachycardia and ventricular fibrillation in a broad range of patients requiring implantable cardioverter defibrillators (ICDs).
Implantation of the Cognis cardiac resynchronisation therapy defibrillator begins in China
The first patient implants of the Cognis (Boston Scientific) cardiac resynchronisation therapy defibrillator (CRT-D) were successfully performed in China's Zhejiang province and Beijing by Farong Shen in Zhejiang Lucheng Hospital and Wei Hua in Beijing Fuwai Hospital.
FDA approval for IntellaTip MiFi XP ablation catheter and 510(k) clearance of Zurpaz 8.5F...
Boston Scientific Corporation has announced it has received US Food and Drug Administration (FDA) approval of its IntellaTip MiFi XP catheter and 510(k) clearance of its Zurpaz 8.5F steerable sheath. The IntellaTip is indicated for ablation of atrial flutter.
FDA clears Rhythmia Mapping System
The Rhythmia Mapping System (Boston Scientific) is a next-generation 3D mapping and navigation solution for use in cardiac catheter ablations and other electrophysiology procedures to diagnose or treat cardiac arrhythmias.
Rhythmia Mapping System gets CE mark
The Rhythmia Mapping System (Boston Scientific) is a next-generation 3D mapping and navigation solution for use in cardiac catheter ablations and other electrophysiology procedures to treat cardiac arrhythmias including: atrial flutter, atrial fibrillation and ventricular tachycardia.
Inliven CRT-P device gets CE mark to treat heart failure
Inliven (Boston Scientific) is the first cardiac resynchronisation therapy pacemaker (CRT-P) using patient's respiration signals to provide physiological pacing and comorbidity management.
PREVAIL shows Watchman device is safe; efficacy is still under discussion
Preliminary results of the PREVAIL trial have demonstrated the Watchman device (Boston Scientific / Atritech) is a safe alternative to oral anticoagulation therapy for stroke prevention in non-valvular atrial fibrillation patients. However, there are now questions towards Watchman's efficacy.
PREVAIL preliminary results of Watchman device to be revealed at ACC 2013
Boston Scientific will present, for the first time, preliminary results of all three co-primary endpoints of the Watchman device at the American College of Cardiology 2013 Annual Scientific Sessions.
FDA approves first subcutaneous implantable defibrillator for patients at risk of sudden cardiac arrest
The S-ICD System (Boston Scientific) sits below the skin without the need of leads to be placed into the heart. This leaves the heart and blood vessels untouched, offering patients an alternative to transvenous implantable cardioverter defibrillators (ICDs).
Watchman Left Atrial Appendage Closure Device receives CE mark approval for expanded use
The Watchman device (Boston Scientific) is indicated to be used in patients with atrial fibrillation and a contraindication to warfarin and the newer oral anticoagulants.
Patient enrolment in PREVAIL study for Watchman device completed
The PREVAIL study is designed to gain FDA approval for the Watchman Left Atrial Appendage (LAA) Closure device (Boston Scientific).
Watchman device shows 75% reduction in stroke risk in patients with atrial fibrillation not...
Vivek Reddy, New York, USA, presented results from the ASA Plavix (ASAP) study of the Watchman Left Atrial Appendage Closure (LAAC) device (Boston Scientific) during a late-breaking session at the Heart Rhythm Society's 33rd Annual Scientific Sessions in Boston, USA.
First Teligen ICDs implanted in China
The Teligen implantable cardioverter defibrillators (Boston Scientific), designed to treat sudden cardiac death, are the smallest high-energy devices available in China.
Watchman device implanted in first patients in Latin America
The Watchman device (Boston Scientific) is designed for use in patients with atrial fibrillation who are at risk for stroke and are eligible for long-term oral anticoagulation therapy such as warfarin. The device is designed to close the left atrial appendage therefore could be used as an alternative to long-term anticoagulation therapy.
Developing a business case for the left atrial appendage occlusion device
Tim Betts, UK, outlined a business case, at the Heart Rhythm congress (2-5 October 2011, Birmingham, UK) to put to commissioners, for using the percutaneous left atrial appendage (LAA) occlusion device (Watchman, Boston Scientific) for stroke prevention in patients with atrial fibrillation.
Blazer Open-Irrigated catheter gets CE mark approval
Boston Scientific's latest radiofrequency ablation catheter is designed to treat a variety of arrhythmias and integrates Total Tip Cooling design which is intended to consistently cool the entire tip electrode during radiofrequency energy delivery.
FDA approves new CRT-D indication for heart failure patients
The three devices from Boston Scientific are intended to treat patients with left bundle branch block who have either mild heart failure or heart failure with no apparent symptoms.
MADIT-RIT enrols first patients
The clinical trial, sponsored by Boston Scientific, was designed to determine which programming strategy best minimises the occurrence of unnecessary therapy in ICD and CRT-D patients.
European approval for the Latitude Patient Management System
Boston Scientific's wireless system remotely monitors patients with implantable cardiac devices and can detects clinical events between scheduled physician visits.
Healthy or hazardous: Study raises “red flag” on wearable smart device interference with CIEDs
A new “red flag-raising” study has provided benchmark data on the safety of smart scales, watches and rings with bioimpedance technology for patients with...
TCT 2022: Amulet occluder keeps pace with Watchman at three years
Long-term follow-up of patients with non-valvular atrial fibrillation (AF) receiving the Amplatzer Amulet left atrial appendage occlusion (LAAO) device have shown continued safety and...
New DAPT labelling approved for Watchman FLX device
Boston Scientific has received US Food and Drug Administration (FDA) approval to expand the instructions for use labelling for the current-generation Watchman FLX left...
Acutus launches expanded suite of left-heart access products
Acutus Medical has announced the commercial launch of an expanded suite of left-heart access products to now include the AcQCross Qx system for use...
TVT 2022: DAPT after Watchman FLX LAAO is comparable to currently approved regimens
Dual antiplatelet therapy (DAPT) after left atrial appendage occlusion (LAAO) using the Watchman FLX (Boston Scientific) device was comparable in terms of rates of...
HRS 2022: S-ICD can be considered as an alternative to transvenous devices in patients...
The use of a subcutaneous-implantable defibrillator (S-ICD, Boston Scientific) reduced the rate of major, lead-related complications by as much as 92% when compared to...
FEops Heartguide receives FDA clearance for LAAO planning capabilities
FEops has announced that it received authorisation from the US Food and Drug Administration (FDA) for FEops Heartguide pre-operative planning of left atrial appendage...
CRT 2022: SURPASS registry shows low rate of adverse events associated with Watchman FLX
Results from a new analysis assessing real-world outcomes with the Watchman FLX (Boston Scientific) left atrial appendage closure (LAAC) demonstrated a low rate of...
Same-day discharge could become the standard strategy following LAAO
A same-day discharge strategy for left atrial appendage occlusion (LAAO) could become the standard approach for this technique, according to the authors of a...
Trial underway to evaluate “modular” cardiac rhythm management system
Boston Scientific has announced the start of the MODULAR ATP clinical trial to evaluate the safety, performance and effectiveness of the mCRM modular therapy...
TCT 2021: SWISS-APERO trial finds lower rate of peri-device leak in Amulet compared to...
Findings of the SWISS-APERO trial, presented at the Transcatheter Cardiovascular Therapeutics annual meeting (TCT 2021, 4–6 November, Orlando USA and virtual), comparing the Amulet...
TCT 2021: LAAC remains non-inferior to NOAC for cardiovascular events at long-term follow-up
Left atrial appendage occlusion (LAAC) remains non-inferior to non vitamin-K-antagonists (NOACs) for the prevention of major cardiovascular, neurological or bleeding events in patients with...
FDA monitoring gender differences in outcomes with LAAO devices
The US Food and Drug Administration (FDA) has informed healthcare providers of recent information about the potential for differences in procedural outcomes between women...
ESC 2021: Abbott’s Amulet occluder shows promise against Watchman device in AF treatment
Abbott has announced late-breaking data from the Amulet LAA Occluder IDE trial, a multicentre, head-to-head study comparing the company's Amplatzer Amulet left atrial appendage...
TVT 2021: Two-year PINNACLE FLX results report low rate of ischaemic stroke for Watchman...
Two-year results from the PINNACLE FLX clinical trial assessing the safety and efficacy of the next-generation Watchman FLX (Boston Scientific) left atrial appendage closure...
Implicity and MicroPort CRM partner for US distribution agreement
Implicity has announced a distribution agreement with MicroPort CRM, through which MicroPort CRM can sell and distribute Implicity's cloud-based solution in the USA as...
ACC.21: Registry data show low rate of stroke at one year following LAAO with...
Transcatheter left atrial appendage occlusion (LAAO) with a Watchman (Boston Scientific) device was associated with a low rate of stroke at one year, even...
EHRA 2021: Subcutaneous ICDs maintain cardioversion efficacy of 98% across five-year study
Subcutaneous implantable cardioverter defibrillator (S-ICD) devices have demonstrated a cardioversion efficacy rate of 98% over a period of at least five years in the...
ControlRad Select imaging system gains FDA market clearance
ControlRad has announced US Food and Drug Administration (FDA) 510(k) clearance to market ControlRad Select, a technology that utilises proprietary semi-transparent filters, a user-interface...
Farapulse gains CE mark for its pulsed field ablation system
Farapulse announced that it has received the CE mark for its pulsed field ablation (PFA) system for the treatment of paroxysmal atrial fibrillation (AF)....
Append Medical completes transcatheter implant-free LAA occlusion procedures
Append Medical, developer of the Appligator implant-free left atrial appendage (LAA) occlusion device, today announced completion of its first pre-clinical chronic procedures. The procedures...
Conformal LAAC studies presented at TCT Connect 2020
Conformal Medical has announced positive clinical data from first-in-human studies performed in the USA and Czech Republic, following trials of its left atrial appendage...
Twin studies demonstrate the evolving S-ICD evidence-base
This advertorial has been sponsored by Boston Scientific
Two landmark studies have been published in 2020 following the use of subcutaneous implantable cardioverter defibrillator (S-ICDs)...
First procedures performed in the USA using Watchman FLX LAAC device
Physicians at the Texas Cardiac Arrhythmia Institute (TCAI) at St David's Medical Center in Austin and Los Robles Health System in Thousand Oaks, became...
Conformal Medical secures funding to support CLAAS device trial
Conformal Medical, a medical device company focused on reducing stroke in patients with atrial fibrillation (AF), today announced it has secured US$85 million in...
Mobile phones and smartwatches pose little risk of CIED interference
The risk of electromagnetic interference to cardiovascular implantable electronic devices (CIEDs) from smartwatches and mobile phones is low—although close proximity between an iPhone 6...
Next-generation Watchman LAAC device gains US FDA approval
Boston Scientific has received US Food and Drug Administration (FDA) approval for the Watchman FLX left atrial appendage closure (LAAC) device. The device is...
€3.7m funding round completed for cardiac AI developer inHEART
inHEART, developer of a cloud-based medical image analysis solution for cardiac interventions on patients with arrhythmias, has closed a funding round of €3.7m led...
PCR e-Course 2020: Roll-in trial finds high device success rate for Amplatzer Amulet occluder
Left atrial appendage occlusion (LAAO) using the Amplatzer Amulet (Abbott) device has a high implant success rate and a low procedural complication rate in...
HRS 2020 Science: UNTOUCHED study finds improved inappropriate shock rate using S-ICD
Findings from the UNTOUCHED study, presented online in a late-breaking trial session at HRS 2020 Science, showed that patients receiving subcutaneous implantable cardioverter defibrillator...
HRS 2020 Science: PRAETORIAN trial demonstrates non-inferiority of S-ICDS compared to transvenous ICDs
Subcutaneous implantable cardioverter defibrillators (S-ICDs) are as protective as transvenous implantable cardioverter-defibrillators (ICDs) in the prevention of sudden cardiac death, but have a better...
Virtual ACC: Largest left atrial appendage occlusion registry finds Watchman acute safety data “very...
Data from the National Cardiovascular Data Registry (NCDR) Left Atrial Appendage Occlusion (LAAO) Registry, which enrolled more than 38,000 patients implanted percutaneously with the...
Novel device “safely obliterates” left atrial appendage with minimal amount left behind
The novel left atrial appendage (LAA) closure device Appligator (Append Medical) was a finalist in the 2019 ICI Innovation Award Competition (Innovation in Cardiovascular...
Leading electrophysiologists identify four key studies that will shape arrhythmia treatment in 2020
Leading electrophysiologists have pinpointed four clinical studies due to report findings in 2020—AMULET IDE, aMAZE IDE, PULSED AF and CEASE AF—that they expect to...
Ed Vertatschitsch joins Bardy Diagnostics as chief operating officer
Bardy Diagnostics (BardyDx) has announced today the appointment of Ed Vertatschitsch as chief operating officer. Effective 2 January 2020, the appointment will see Vertatschitsch...
BIBA Briefings: Longest and largest follow-up data for Watchman supports its role in stroke...
Data from the CAP and CAP2 registries—which contain the longest and largest follow-up of patients—add to previous evidence that left atrial appendage closure (LAAC)...
Left atrial appendage closure associated with a decreased stroke risk in AF patients
Left atrial appendage closure (LAAC) via implanted device was associated with a decreased risk of admission for stroke, compared with the expected risk without...
AtriCure agrees to buy LARIAT developer SentreHEART
AtriCure has entered into a definitive agreement to acquire SentreHEART, which developed the LARIAT device for left atrial appendage closure in patients with atrial...
ESC 2019: Left atrial appendage closure is non-inferior to NOACS for preventing neurological events
At the 2019 European Society of Cardiology (ESC) Congress (31 August–4 September, Paris, France), Pavel Osmancik (Charles University and University Hospital Kralovske Vinohrady, Prague,...
Pooled analysis shows LAAC is cheaper than drug therapy for AF
A pooled analysis of five-year data from the PROTECT AF and PREVAIL trials has shown left atrial appendage closure (LAAC) to be cost‐effective, and...
White paper from Heart Rhythm Society suggests Afib treatment has reached a “turning point”
The Heart Rhythm Society has published a white paper looking at the consequences of oral anticoagulants for managing stroke risk in atrial fibrillation which...
UNTOUCHED finds high conversion efficacy and low adverse event rate for Emblem S-ICD
The Emblem subcutaneous implantable defibrillator system (S-ICD; Boston Scientific) demonstrated a high conversion efficacy and low adverse event rate. Data from the UNTOUCHED trial...
Luminize demonstrates safety and efficacy at 30 days
The Luminize (Boston Scientific) radiofrequency balloon catheter is safe and effective at 30 days in the treatment of atrial fibrillation, data from the AF-FICIENT...
Late-breaking trial highlights positive safety and efficacy data for the LUMINIZE RF balloon catheter
Boston Scientific announced data from the AF-FICIENT I study during a late-breaking clinical trial session at the 2019 European Heart Rhythm Association annual congress...
CE mark for Watchman FLX left atrial appendage closure device
Boston Scientific announced it has received CE mark and initiated a limited market release of the next generation Watchman FLX left atrial appendage closure...
The first 60 years of cardiac pacing
Sixty years ago, the first pacemaker implant was made in Stockholm, Sweden (Senning & Elmqvist) on 8 October 1958. The patient had atrioventricular block...
Tim Betts
For Tim Betts, a career in medicine was a natural choice. After graduating he knew he wanted to be a cardiologist and, with a...
Simultaneous TAVI and left atrial appendage closure is feasible
Thomas S Gilhofer (University Heart Center, Department of Cardiology, University Hospital Zurich, Zurich, Switzerland) and others report in Structural Heart that a combined procedure...
Late-breaking data highlight reduction in rate of inappropriate shocks with sensing filter
The SMART Pass sensing filter (Boston Scientific), when in patients implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System, successfully reduces inappropriate shocks. This...
Case report: Usefulness of high resolution mapping with mini-electrodes to select ablation site...
This article has been sponsored by Boston Scientific.
Case description
A 62-year-old woman, with recent sinus venosus atrial septal defect correction surgery, developed a persistent macroreentrant...
DEEP-guided ablation may enable better treatment of ventricular tachycardia
Results from a multicentre study of catheter ablation guided by DEEP (decrement-evoke potential) mapping show that using DEEP mapping meant that ablation was successful...
Obesity may make subcutaneous implantable cardioverter-defibrillators less effective during testing
Obese patients are at a higher risk of failed first subcutaneous implantable cardioverter-defibrillator (S-ICD) shocks during defibrillation testing. This is what a group from...
Short-term DAPT is feasible for patients undergoing percutaneous LAA closure
Felix Weise (Cardioangiologisches Centrum Bethanien, Frankfurt, Germany) and others report in EuroIntervention that a strategy of six weeks’ duration of dual antiplatelet therapy (DAPT)...
Respicardia announces first U.S. commercial case with the remedē system
Respicardia, Inc., a medical technology company developing therapies that improve cardiovascular health, have announced the first U.S. commercial case using the remedē system to...
Vivek Reddy on the final outcomes of PREVAIL and PROTECT-AF
Boston Scientific has announced the final five-year outcomes data from the PREVAIL study during a late-breaking clinical trial session at this year’s Transcatheter Cardiovascular...
Analysis of LAA closure devices reveals post-approval spike in safety events
A retrospective study conducting a safety assessment and comparison between two percutaneous devices commonly used for left atrial appendage (LAA) closure in the US...
Data confirm HeartLogic Diagnostic helps to categorise patients at low or high risk of...
Boston Scientific has announced new data from the MultiSENSE (Multisensor chronic evaluation in ambulatory heart failure patients) study, which is evaluating the performance of...
EHRA Inventors Award ideas focus on cardiac remote monitoring and CRT optimisation
For the second-year running, the European Heart Rhythm Association (EHRA) held the EHRA Inventors Award competition at EHRA-EUROPACE CARDIOSTIM (18‒21 June, Vienna, Austria), a...
Europace 2017: Thrombus formation on left atrial appendage occlusion devices strongly associated with higher...
A French multicentre analysis of left atrial appendage (LAA) occlusion for stroke prevention in atrial fibrillation patients has found a 5.3% rate of thrombus...
S-ICD technology continues to advance rapidly
The benefits of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD, Boston Scientific) over transvenous (TV)-ICD, including lower rates of lead-related complications and lower in-hospital complication...
HRS 2017: Watchman prevents stroke even in high-risk patients: One-year follow-up of EWOLUTION registry...
Left atrial appendage closure with the Watchman device (Boston Scientific) is safe and effective at stroke prevention, with a high implant and sealing success,...
MADIT S-ICD global study enrols first patient to assess sudden cardiac arrest prevention in...
Boston Scientific has initiated a worldwide study (MADIT S-ICD) that will evaluate the survival benefit of patients treated with the Emblem MRI Subcutaneous Implantable...
Modular cardiovascular device communication: A step towards artificial intelligence to treat cardiovascular disease
The implantable cardioverter defibrillator (ICD) is a well-established therapy for the prevention of sudden cardiac death. However, it is still associated with complications over...
Occlutech left atrial appendage occluder shows high procedural success in first-in-man experience
The first-in-man study exploring the safety, feasibility and neurological outcome with the Occlutech left atrial appendage (LAA) occluder (Occlutech) has shown a 93% procedural...
Advances in non-invasive imaging to treat ventricular tachycardia and prevent sudden cardiac death
We are standing at a crossroads of non-invasive imaging technologies in the field of electrophysiology. Advances in cardiac magnetic resonance imaging (CMRI) mean that...
AHA 2016: Multisensor algorithm may help predict worsening heart failure
Results from the MultiSENSE study have demonstrated that a new multisensor algorithm, the HeartLogic Heart Failure Diagnostic Service (Boston Scientific), provides a timely alert...
“We still have a long way to go to understand the benefits of remote...
In light of the recently presented results from REM-HF and MORE-CARE trials, Gerhard Hindricks and Nikolaos Dagres, both from Leipzig University Heart Center, Leipzig,...
CardioFocus announces new management appointments
CardioFocus has announced the appointment of Omari Bouknight as chief commercial officer and Jeff Rynbrandt as vice president of US Sales. Together they will lead the commercialisation of...
ESC 2016: Remote monitoring for heart failure may not improve clinical outcomes
Two randomised clinical trials presented at a Hot Line session of the European Society of Cardiology Congress (ESC; 27‒31 August, Rome, Italy) have shown...
No significant differences between Watchman and Amplatzer in first comparison
Results from the first study to compare outcomes of two left atrial appendage closure devices—Watchman (Boston Scientific) and Amplatzer (St Jude Medical)—indicate that there...
Educational supplement: LAA closure for stroke prophylaxis in atrial fibrillation
This educational supplement is only for readers in countries outside France, Japan and the USA
In this educational supplement, sponsored by Boston Scientific, Cardiac Rhythm News explores left...
Three-month data for Watchman show high success rate
New data from the EWOLUTION registry, presented at EuroPCR 2016, confirms safety of the Boston Scientific left atrial appendage closure system (Watchman). The data...
Hypertrophic cardiomyopathy patients at risk of sudden cardiac death may be eligible for S-ICD
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.
FDA Panel provides recommendations on adverse events, long-term safety and postmarket surveillance of leadless...
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.
Advances in left atrial appendage occlusion and peri-procedural challenges
Dhiraj Gupta (Liverpool, UK) overviews developments in two left atrial appendage (LAA) occlusion devices, which have helped make the implant procedure safer, easier and quicker. He also highlights current challenges related to overall peri-procedural patient management.
An interventional cardiologist’s view on left atrial appendage closure
By Martin W Bergmann
Martin W Bergmann is an interventional cardiologist working in Germany, who performs percutaneous left atrial appendage (LAA) closure procedures. He explores...
Acutus Medical expands leadership team
John Dahldorf, Martin Chambers and Steven McQuillan join the company as chief financial officer, chief commercial officer and senior vice president, Regulatory and Clinical Affairs, respectively.
ESC recommends subcutaneous defibrillators for management of ventricular arrhythmias and prevention of sudden cardiac...
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.
Off-label use of the Lariat device for left atrial appendage exclusion questioned
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.
FDA reports adverse events with the Lariat device for left atrial appendage closure
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.
Entirely Subcutaneous ICD (S-ICD) poised to revolutionise treatment of Sudden Cardiac Death
The publication of important new long-term data from nearly 900 patients and a rapid evolution in the technology is putting entirely the Subcutaneous Implantable...
Targeting the left atrial appendage for AF-related stroke prevention: Why the heart team is...
Sacha Salzberg cardiovascular surgeon (Heart Clinic Hirslanden, Cardiac Surgery Unit, Zurich, Switzerland) comments on catheter-based and surgical approaches for left atrial appendage occlusion as...
Subcutaneous-ICD patients may be able to undergo MRI scans at 1.5T safely
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.
Highlights from ISCAT 2014
Michel Haissaguerre and Etienne M Aliot, chairmen of the International Symposium on Catheter Ablation Techniques (ISCAT; 15-17 October 2014, Paris, France), discuss the highlights of this year's meeting with Cardiac Rhythm News.
First randomised sham controlled trial of vagal nerve stimulation for heart failure treatment fails
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.
Antithrombotic therapy after left atrial appendage closure
Uncertainty exists about the optimal post-interventional antithrombotic drug regimen as well as treatment duration after left atrial appendage closure; Boris Schmidt and KR Julian...
Defibrillation testing: Safe but not necessary
Results from the SIMPLE study show that despite the fact that defibrillation threshold testing at the time of device implantation is generally safe, it does not improve implantable cardioverter defibrillator (ICD) shock efficacy or reduce mortality compared to a no-testing strategy.
Advanced Cardiac Therapeutics announces new financing for TempaSure cardiac ablation catheter for treatment of...
The financing, which was led by New Enterprise Associates and supported by existing investor, NBGI Ventures, will enable the company to continue to advance its next generation TempaSure ablation catheters and related clinical development programme.
FDA advisory panel votes favourably on Watchman left atrial appendage closure device
On 11 December, the FDA's Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favourably by a majority, Yes: 13, No: 1, that the benefits of the Watchman left atrial appendage closure device outweigh the risks.
First patient enrolled in EWOLUTION registry for Watchman device
EWOLUTION is a multinational, prospective, multicentre, post market registry aimed to collect data on procedural success, incidence of stroke and mortality of patients implanted with a Watchman device.
Discrepancies in CRT-ICD battery longevity
An independent study demonstrates significant differences in battery longevity between cardiac resynchronisation therapy (CRT) implantable cardioverter defibrillators (ICDs), which are still implanted today worldwide.
Chinese electrophysiology market to grow approximately 20% in 2013
According to research by the Millennium Research Group, the Chinese electrophysiology market will grow approximately 20% in 2013, based on the largest available sampling of ablation procedures.
Remote monitoring of ICD patients: What is the patients’ opinion?
Werner Jung (Villingen-Schwenningen, Germany) revises patients' opinions regarding remote monitoring of implantable cardiac defibrillators (ICDs). He spoke on the subject at the European Heart Rhythm Association (EHRA) Europace meeting (23-26 June, Athens, Greece).
Lower electrode-related complication rate for S-ICD system vs transvenous ICD leads
Outcomes of an analysis, presented at European Heart Rhythm Association (EHRA) Europace 2013, followed recent NICE guidance supporting safety and effectiveness of subcutaneous implantable defibrillators.
Effectiveness of left atrial appendage exclusion, ligation and occlusion in reducing stroke risk in...
Andre d'Avila and Arash Aryana write on three different left atrial appendage strategies aimed to reduce stroke risk in atrial fibrillation patients. d'Avila presented this analysis at Heart Rhythm (Denver, USA, 8-5 May 2013).
Weight loss may increase risk of cardiac events in patients implanted with defibrillators
Even minor weight loss is associated with worse health outcomes among patients implanted with cardiac resynchronisation therapy with defibrillator (CRT-D), according to research presented by Valentina Kutyifa, Rochester, USA, at ACC 2013.
Syncope events in bifascicular block patients can be reduced with permanent dual chamber pacing,...
Massimo Santini, Rome, Italy, and others have recently published results from the PRESS study. They found that by using a dual chamber pacemaker programmed to 60ppm lower rate the number of syncope events can be reduced in bifascicular block patients.
Long-term results of PROTECT AF confirm left atrial appendage closure is non-inferior to warfarin
Vivek Y Reddy, Mount Sinai School of Medicine, New York, USA, and others recently reported the updated results ahead of print in Circulation.
First patient treated in trial to evaluate the safety and performance of the Blazer...
The ZERO AF study will include up to 33 sites in the USA, Europe and Asia-Pacific, and the results will be used to support a FDA submission for a paroxysmal AF indication.
MADIT-RIT trial shows improved device programming reduces inappropriate therapy and risk of death for...
Data presented at the American Heart Association Scientific Sessions have shown that improved programming of dual-chamber implantable cardioverter defibrillators or cardiac resynchronisation therapy defibrillators can reduce inappropriate therapy by up to nearly 80% and increase patient survival by up to 55%.
Percutaneous left atrial appendage suture closure can be performed effectively, study shows
Krzysztof Bartus, Krakow, Poland, and colleagues have reported that left atrial appendage closure for stroke prevention in patients with atrial fibrillation using a percutaneous ligation approach can be performed effectively and is associated with a low rate of complications.
Ingenio and Advantio pacemakers receive CE mark approval for use in patients requiring MRI...
With the Image Ready technology, Ingenio MRI pacemakers, in combination with Fineline II leads, allow patients to undergo MRI procedures as needed.
First patient active with Latitude NXT Remote Patient Management System
The system offers wireless and automatic remote follow-up and optional integrated cellular GSM connectivity.
Cameron Health’s S-ICD System meets primary safety and efficacy endpoints in IDE clinical study
Martin C Burke, University of Chicago, USA, presented the results of the S-ICD System investigational device exemption clinical trial at a late-breaking session at the Heart Rhythm Society's 33rd Annual Scientific Sessions (9-12 May, Boston, USA).
The European cardiac rhythm management, electrophysiology and ablation market valued at over €2.8 billion...
These markets could reach over €4.4 billion by 2017, according to a report published by iData Research.
Analysis of patients monitored by the Latitude System shows relative reduction in risk of...
The analysis also showed that heart failure patients who transmitted weight and blood pressure data via the system experienced an additional 10% reduction in the risk of death.
Implanted devices as effective in “real world” as in clinical trial settings
Study published in Circulation showed that, after one year, 92% of ICD recipients and 88% of CRT-D patients were alive. Survival rates after five years were 68% for ICD and 54% for CRT-D.
Standard pacing therapy regulates heart pumping as well as costly tailored methods
Study shows that cardiac resynchronisation therapy is as effective as two other methods that regulate the time interval between the squeezing of the heart's upper and lower chambers.
FDA approves devices for heart failure patients
A new indication for three cardiac resynchronisation therapy defibrillators can be used for patients with an abnormality known as left bundle branch block.
MultiSENSE trial enrolment gets underway
Study has been designed to evaluate multiple physiologic sensors in cardiac resynchronisation therapy defibrillators.
MADIT-CRT data show women received greater benefit from CRT-Ds than men
The sub-analysis demonstrated that both men and women experienced benefit from CRT but women experienced a 70% reduction in heart failure events compared to a 35% reduction for men.
Guidant pleads guilty for not reporting defibrillator safety problems to FDA
Medical device manufacturer will pay criminal penalty of more than US$296 million for violations of the US Federal Food, Drug and Cosmetic Act.
FDA Advisory Panel recommends expanded CRT indication for heart failure
The panel unanimous decision extends resynchronisation therapy for asymptomatic and mild heart failure patients based on landmark MADIT-CRT trial.
St Jude Medical announces sponsorship of SCD-HeFT 10-year Follow-up Study
New study will revisit patients from the groundbreaking SCD-HeFT trial to collect long-term data regarding the efficacy of ICDs in heart failure patients.
“MADIT-CRT shows compelling results”
Asymptomatic or mildly symptomatic cardiac patients randomised to an implanted CRT-D have a 34% lower risk of heart failure or death than those receiving a standard ICD.
PreSCD II Registry shows ICDs lead to 44% reduction in mortality for infarction survivors
The mortality reduction trend was also observed in high-risk patients with severely reduced heart function.
New MADIT II data analysis shows long-term survival benefit for implantable defibrillator therapy
At eight years, one life is saved for every six patients who receive an ICD, according to data presented at Heart Rhythm 2009.
Increasing use of ablation to treat atrial fibrillation
American report says number of catheter ablation procedures for treating atrial fibrillation will fuel revenues in the electrophysiology ablation catheter market over the next five years.
Results of cuffless blood pressure monitor presented at AHA Hypertension Sessions
Results of an analysis of Aktiia’s cuffless blood pressure (BP) monitoring system are being presented at the American Heart Association (AHA) Hypertension Scientific Sessions...
Genetic “cure” for cardiomyopathy is selected as winner of Big Beat Challenge
A project to develop genetic therapies to effectively cure cardiomyopathy has been announced as the winner of the British Heart Foundation’s Big Beat Challenge,...
AI algorithms to be added to Medtronic’s LINQ II ICMs in Europe
Medtronic has announced two AccuRhythm AI algorithms will be applied to LINQ II insertable cardiac monitors (ICM) through cloud-based updates in Europe later this...
AHA 2021: Fitbit shows promise for detection of AF
Results of the Fitbit Heart study, presented during a late-breaking science session at the American Heart Association’s Scientific Sessions 2021 (AHA 2021; 13–15 November;...
HRS 2021: Early VT catheter ablation beats medical therapy in patients at risk for...
Results of the PAUSE-SCD trial show a significant reduction in risk of ventricular tachycardia (VT) recurrence, cardiovascular hospitalisation, and death when catheter ablation is...
Abiomed acquires breakthrough device company preCARDIA
Abiomed has acquired preCARDIA, developer of a proprietary catheter and controller to expand options for patients with acute decompensated heart failure (ADHF). The preCARDIA...
AHA 2020: InCarda announces presentation of INSTANT trial data
InCarda Therapeutics has announced the presentation of positive data from the open-label, dose-escalation Part A portion of the company’s multinational INSTANT Phase 2 clinical...
American Heart Association appoints Mitchell Elkind as president
The American Heart Association (AHA) has named Mitchell SV Elkind as president of the organisation for its 2020–2021 fiscal year, which began on 1...
The evolution of cardiac care in the wake of COVID-19
David E Albert, founder and chief medical officer of AliveCor, considers the impact of the COVID-19 pandemic on the monitoring and of management of...
AI study launched to monitor cardiac safety of COVID-19 patients receiving hydroxychloroquine
Cardiologs has announced the launch of a clinical study using the company’s artificial intelligence (AI) solution to remotely monitor the cardiac safety of COVID-19...
Virtual ACC: Mavacamten “promising” in treatment of non-obstructive hypertrophic cardiomyopathy
Results from the phase 2 MAVERICK-HCM clinical trial, presented at the American College of Cardiology/World Congress of Cardiology’s virtual scientific sessions (ACC.20/WCC Virtual) suggest that...
Virtual ACC: LivaNova highlights Vitaria data
Data on the use of LivaNova’s implantable neuromodulation technology, Vitaria, for heart failure patients has been shared at the American College of Cardiology/World Congress...
High power short duration ablation for atrial fibrillation: Safety and effectiveness
As part of a session on novel mapping and ablation technologies of atrial fibrillation (AF) at the recent AF Symposium in Boston, USA (24–26...
AHA 2018: Computerised-decision support has the potential to be a “powerful tool” for preventing...
Data presented at the 2018 American Heart Association (AHA) scientific session scientific sessions (10–12 November, Chicago, USA) indicate that the use of alert-based computerised-decision...
CABANA trial provides important new data on clinical and quality of life effects of...
Catheter ablation for atrial fibrillation (AF) produced no significant improvement in death, disabling stroke, serious bleeding, or cardiac arrest but did reduce death or...
More than US$28 million awarded for new atrial fibrillation research centres to improve patient...
The American Heart Association has announced research grants totalling more than US$28 million to the scientific teams that will create a new research network...
Luigi Di Biase
Luigi Di Biase is a prominent electrophysiologist, section head of Electrophysiology, director of Arrhythmia Services, and professor of Medicine (Cardiology) at the Albert Einstein...
Real-world data demonstrates success of SMART Pass on the S-ICD System
Results from an analysis of the LATITUDE database which evaluated the successful reduction of inappropriate shocks using the SMART Pass sensing filter in patients...
AI used to detect ‘invisible’ heart condition
Investigators from the Mayo Clinic and AliveCor demonstrated that a trained artificial intelligence network can help identify people with increased risks of arrhythmias...
Cardiac contractility modulation in heart failure treatment is safe
Cardiac contractility modulation (CCM) in heart failure is safe, the results from the FIX-HF-5C randomised controlled trial demonstrate, with all primary and secondary safety...
Late-breaking presentation at Heart Rhythm 2018 shows potential for more patients to benefit from...
An investigational algorithm, utilising the accelerometer signal in the Micra Transcatheter Pacing System (TPS) (Medtronic) may restore AV synchrony, improving cardiac function in patients...
New long-term data show improved survival and lower rates of stroke and pump thrombosis...
New late-breaking clinical trial data from the MOMENTUM 3 clinical study shows overall survival of 83% at 2-years and marked improvement in clinical outcomes for...
US Patent Office allows AblaCor five ablation catheter-anchoring patents
AblaCor medical corporation has announced that it has received a notice of allowance from the United States Patent & Trademark Office on five additional patents for...
Thomas F Deering
Thomas F Deering (Piedmont Heart Institute, Atlanta, USA) considers that the biggest challenge in electrophysiology (EP) is to “move from the volume to the...
ACC 2017: Real-world study supports the effectiveness of the CardioMEMS HF system in reducing...
A study outside the clinical trial setting, which included US Medicare patients, has shown the effectiveness of the CardioMEMS HF system (Abbott) to significantly...
AHA 2016: HeartMate 3 LVAS improves clinical outcomes compared with HeartMate II LVAS
A prespecified primary analysis of the MOMENTUM 3 US IDE clinical study has indicated improvement in clinical outcomes for advanced heart failure patients implanted...
AHA 2016: Low-dose rivaroxaban reduces clinically significant bleeding in PCI patients with atrial fibrillation
Two drug regimens involving low doses of rivaroxaban (Xarelto, Bayer)—one with a 15mg once daily dose of the drug and a P2Y12 inhibitor and...
Patent foramen ovale closure is more effective than medical management in preventing recurrent stroke
Final results from the RESPECT trial found that percutaneously closing a patent foramen ovale (PFO) using the Amplatzer PFO Occluder (St Jude Medical) was...
Jeremy Ruskin
Jeremy Ruskin (Boston, USA), professor of medicine Harvard Medical School and director emeritus of the Cardiac Arrhythmia Service and Clinical Electrophysiology Laboratory at Mass...
EBR Systems receives FDA approval to begin IDE study of its wireless endocardial pacing...
EBR Systems has announced the US Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) for its WiSE (Wireless Stimulation Endocardially) technology for cardiac...
How innovation can unleash tremendous growth in the $3.4 billion AF ablation market
Shlomo Ben-Haim (London, UK), a professor of medicine and serial entrepreneur in the medical device industry, examines the drivers of expansion of the atrial...
First wireless cardiac pacing system for heart failure receives the CE mark
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).
Michael Gold
William Gold spoke to Cardiac Rhythm News about his involvement in various clinical trials, his views on the upcoming treatment options for heart failure and the highlights of this year's HRS meeting.
Medtronic Tyrx antibacterial envelope reduces cardiac device infection rates at 12 months
Long-term Citadel/Centurion clinical trial findings and independent data presented at Heart Rhythm Society 36th Annual Scientific Sessions.
Botox reduces AF burden for up to a year after cardiac surgery
Botulinum toxin injected into epicardial fat pads during coronary artery bypass graft surgery reduced the incidence of postoperative atrial fibrillation compared with placebo, with substantial suppression persisting after one year, a pilot study has found.
Cardiac resynchronisation is possible by leadless endocardial pacing of the left ventricle, new study...
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.
Activity after ICD implantation may predict survival
In the largest study on the relationship between activity and survival in ICD patients, researchers analysed how active participants were in the first 30-60 days after implantation and then over time up to four years.
Global trial finds Medtronic Micra transcatheter pacemaker meets initial safety measures in wide range...
All of the first 140 patients in the trial were successfully implanted with the Micra TPS. The data were presented at Heart Rhythm 2015 (13-16 May, Boston, USA).
Data shows advantages of Acutus Medical Dipole Density Heart Imaging and Mapping System in...
The data was presented at the Heart Rhythm Society's 36th Annual Scientific Sessions (13-16 May, Boston, USA) and shows the systems benefits compared with standard voltage-based mapping in patients with atrial flutter.
HeartLight US pivotal study meets primary efficacy and safety endpoints
The trial, which randomised CardioFocus' HeartLight one-to-one versus the Biosense Webster Thermocool catheter, met both primary efficacy and safety endpoints and demonstrated a low learning curve for physicians.
Middle-aged congenital heart disease survivors may need special care
For the first time, the American Heart Association has issued recommendations for healthcare providers treating people older than 40 with congenital heart disease.
Radiation risks should be considered and discussed before heart imaging: American Heart Association urges
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.
Dennis, Antman to lead American Heart Association in 2014-15
The American Heart Association has announced its national officers for the 2014-15 fiscal year, which begins July 1.
Richard Fogel
Richard Fogel, president-elect of the Heart Rhythm Society and chief executive officer at St Vincent Medical Group, considers he entered the field of electrophysiology at "the perfect time" when radiofrequency ablation and implantable cardiac defibrillators were emerging as a therapy to treat cardiac rhythm disorders. He spoke with Cardiac Rhythm News about this work, his interests in research and policy and the highlights of this year's Heart Rhythm Society's scientific sessions.
Pediatric and Congenital Electrophysiology Society recommends higher standards for the advancement of fellowship training
The Training and Credentialing Committee of the Pediatric and Congenital Electrophysiology Society (PACES) has launched a comprehensive review of advanced electrophysiology fellowships in an effort to ensure the highest possible standards for training programmes and practitioners in the field.
Convergent procedure building support for interdisciplinary approach to atrial fibrillation
An article in the Journal of Cardiovascular Electrophysiology outlines the development and results of the new interdisciplinary procedure, the convergent procedure
Data presented at HRS 2012 suggest Convergent Procedure ablation may restore persistent atrial fibrillation...
nContact has announced that new long-term physician data demonstrated promising clinical outcomes for the multidisciplinary Convergent Procedure in the treatment of persistent atrial fibrillation (AF), with over 80% of patients remaining in sinus rhythm at a minimum of 12 months follow-up.
Anne Gillis: new president of the Heart Rhythm Society
The announcement was made at the Presidents' Reception on Friday 11 May. Gillis now serves as the 34th president of HRS and the second international president preceded by Bernard S Goldman, (1982-1983).
Symposium on epicardial approach to posterior cardiac ablation convened at Heart Rhythm 2012
Electrophysiology thought leaders gathered to discuss the significance of posterior ablation in the treatment of arrhythmias, with presentations highlighting the importance of isolating the posterior left atrium with an adjunctive epicardial treatment.
Stereotaxis technology to be showcased at the Heart Rhythm Society annual meeting
Stereotaxis has announced that a total of 11 invited podium presentations will feature the use of Stereotaxis magnetic navigation technology in a wide variety of arrhythmias.
Worldwide multicentre experiences with HeartLight EAS to be presented at Heart Rhythm 2012
CardioFocus has announced that its HeartLight Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation will be highlighted both as part of the scientific sessions and during a private academic symposium at the Heart Rhythm Society's 33rd Annual Scientific Sessions (9-12 May, Boston, USA).
Biotronik to showcase world’s first ICD, CRT-D and CRT-P devices with ProMRI technology at...
Biotronik will showcase the Lumax 740 ICD and CRT-D series and the Evia HF-T with ProMRI, a technology that allows patients requiring tachycardia and heart failure therapies to have access to magnetic resonance imaging.
Hugh Calkins
Hugh Calkins, chair of the upcoming Heart Rhythm 2012─Scientific Sessions Program Committee, spoke to Cardiac Rhythm News about his career highlights, Heart Rhythm 2012, and the new consensus document on catheter and surgical ablation of atrial fibrillation.
Does moderate alcohol consumption increase the risk of atrial fibrillation?
Even moderate alcohol consumption can lead to the development of atrial fibrillation, according to researchers from the University of Tsukuba, Institute of Clinical Medicine, Mito, Japan.
Study shows fluid monitoring more accurate than weight measures for heart failure patients
Results showed that Medtronic OptiVol Fluid Status Monitoring predicted 76% of future heart failure events as compared to only 23% detected by weight monitoring alone.
XPECT: Monitoring AF with a minimally invasive device
John Camm, London, UK, analyses the first MRI approved insertable cardiac monitor (ICM) featuring an automatic AF detection algorithm.
CardioFocus receives CE mark for AF ablation catheter
The device incorporates a micro-endoscope and light energy fibres to give physicians the capacity to see within the heart and visually direct the application of energy through a catheter.
Expert consensus statement on the catheter ablation of ventricular arrhythmias is released
State-of-the-art review of catheter ablation of VT by an international panel of experts was released during the Heart Rhythm Society's 30th Annual Scientific Sessions.
Endosense receives CE mark for TactiCath force-sensing ablation catheter
Approval was granted based on select data submitted from the TOCCATA clinical study, which was performed by 17 experienced investigators at eight European centres.
Implantable defibrillators, pacemakers affected by MP3 headphones
Headphones for MP3 players placed within an inch of pacemakers and implantable cardioverter defibrillators may interfere with these devices, according to research presented at the AHA's Scientific Sessions 2008.
