OSYPKA AG, a medical device company based in Rheinfelden, Germany, has received the CE mark under the European Union’s Medical Device Regulation (MDR) for a class III cardiac pacing electrode. “This is a new milestone that is also valuable for...
The Heart Rhythm Society (HRS) has announced the full line-up of speakers and sessions for its first annual HRX meeting (8–10 September, San Diego, USA). The conference offers clinicians, engineers, product developers, investors, entrepreneurs, non-profit organisations, and patient advocacy groups...
Projected rates of cardiovascular risk factors and disease will increase significantly in the USA by 2060, a study published in the Journal of the American College of Cardiology (JACC) has claimed. Substantial increases in cardiovascular trends may contribute to a...
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, a £30 million innovation project targeting unmet needs in heart disease. CureHeart—a project involving researchers from...
Adagio Medical has announced the publication of the results of its Cryocure-2 ultra-low temperature cryoablation (ULTC) study in patients with atrial fibrillation (AF) in the Journal of American College of Cardiology (JACC), Clinical Electrophysiology. The study prospectively enrolled 79 patients...
InCarda Therapeutics has announced enrolment of the first patient in the company’s pivotal phase 3 RESTORE-1 clinical trial of InRhythm (orally inhaled flecainide) in patients with newly-diagnosed atrial fibrillation (AF) or recurrent paroxysmal atrial fibrillation (PAF). At an end-of-phase 2...
Acutus Medical has announced approval of its AcQMap high resolution imaging and mapping system and the AcQMap 3D imaging and mapping catheter in Japan. Acutus’ International Alliance partner Biotronik has commenced training and early market development activities in collaboration with...
iRhythm Technologies has received US Food and Drug Administration (FDA) 510(k) clearance for its ZEUS (Zio ECG Utilization Software) system for the Zio Watch. Produced in partnership with Verily, the ZEUS system combines deep learned algorithms with a cardiac arrhythmia...
Acutus Medical has announced that David Roman has been appointed president and chief executive officer, and member of the Board of Directors, effective immediately. The company also announced preliminary second quarter revenue results. Roman, who joined the company as chief...
Around 80% of patients diagnosed with atrial fibrillation (AF) in the UK population are eligible for early rhythm control, an analysis of the EAST-AFNET 4 trial, published in Heart, has found. Rhythm control therapy is typically delayed unless patients have...
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 to provide remote support to a number of hospitals in Europe, Africa and the Middle...
A research project at the University of Leeds (Leeds, UK) aiming to find an easier way to establish the optimum heart rate for heart failure patients with pacemakers, has received a £200,000 grant from Heart Research UK. According to researchers,...
Stereotaxis has announced the CE mark submission for its MAGiC catheter, a robotically navigated magnetic interventional ablation catheter for minimally invasive cardiac ablation procedures. MAGiC is used in conjunction with Stereotaxis’ robotic systems and designed to provide catheter precision, stability...
Abbott has introduced its EnSite X EP a cardiac mapping platform with EnSite Omnipolar Technology (OT) in Canada. The platform allows for the creation of a 3D model of the patient’s cardiac anatomy in real-time, improving how physicians identify and...
Biotronik’s LiveSupport feature was used to remotely support two Biomonitor implantable cardiac monitor (ICM) implants shortly after launch. Both procedures were performed with a Biotronik representative in a remote location. Developed in part as a response to the COVID-19 pandemic,...
Catheter ablation of atrial fibrillation (AF) was economically attractive compared with drug therapy in the CABANA (Catheter ablation versus antiarrhythmic drug therapy for atrial fibrillation) trial, investigators have reported in Circulation. CABANA was an investigator-initiated, open-label, multicentre, randomised trial in...
Cardiac testing company CardiNor AS has announced that it has signed an exclusive agreement with IBL-America for sales of the CardiNor Secretoneurin ELISA test in the USA. By initially targeting research institutes, clinical research organisations and pharmaceutical companies, the company...
HeartBeam is expanding the available patient population for its emergency department software technology solution. In evaluating the electrocardiogram (ECG) database for the clinical validation of HeartBeam’s platform technology, a significant portion of consecutive patients fell into the category of...
Acutus Medical has announced the completion of the first of two closings for its previously disclosed sale of the company’s left-heart access portfolio to Medtronic. Additionally, Acutus Medical has also announced entry into a new longer-term credit facility with Deerfield...
People who develop an arrhythmia after surgery have an increased risk of subsequently being admitted to hospital with heart failure, according to a study of over three million patients published in the European Heart Journal. The study showed that...
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 with the TruSeal and FXD delivery system for the Watchman left atrial appendage closure (LAAC)...
In patients treated with pulsed field ablation (PFA) for symptomatic paroxysmal atrial fibrillation (AF), the incidence of asymptomatic thromboembolic cerebral events or lesions detected by magnetic resonance imaging (MRI) was as low as 3%. This is according to the...
A study, published in the European Heart Journal–Digital Health, shows the predictive potential of a deep-learning model in identifying patients at risk of atrial fibrillation (AF) following monitoring with a 24-hour ambulatory electrocardiogram (ECG), despite no documented prior AF,...
Recommendations on how to use gene testing to prevent sudden cardiac death in athletes and enable safe exercise have been published in the European Journal of Preventive Cardiology. “Genetic testing for potentially lethal variants is more accessible than ever before...
A national, multicentre registry investigating the safety and efficacy of laser lead extraction has reported high success- and low procedure-related complication rates associated with the procedure. This is the headline finding of the GALLERY (German laser lead extraction gallery)...
Conformal Medical has announced the launch of the CONFORM pivotal trial with the enrolment of the first patients at two US sites. The investigational device exemption (IDE) study will evaluate the safety and efficacy of the company's CLAAS system compared...
Dual antiplatelet therapy (DAPT) after left atrial appendage occlusion (LAAO) using the Watchman FLX (Boston Scientific) device was comparable in terms of rates of death, stroke, bleeding or device-related thrombus when compared to use of aspirin with an anticoagulant,...
Incidence of ventricular arrhythmias can be linked to days when air pollution is high, according to research presented at Heart Failure 2022 (21–24 May, Madrid, Spain). The study was conducted in patients with an implantable cardioverter defibrillator (ICD), enabling...
AtriCure has announced that the first patient has been treated in the HEAL-IST trial, evaluating the safety and effectiveness of AtriCure’s Isolator Synergy Clamp for the treatment of drug-refractory patients diagnosed with inappropriate sinus tachycardia (IST). The first patient...
Abbott has announced that the US Food and Drug Administration (FDA) has approved the Aveir single-chamber (VR) leadless pacemaker for the treatment of patients in the US with slow heart rhythms. The Aveir leadless pacemaker is implanted directly inside the...
A study has revealed the “global collateral damage” caused by the disruption to cardiac services caused by the COVID-19 pandemic. Writing in the European Heart Journal, researchers warn that problems with heart health will “...continue to accrue unless mitigation...
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 a transvenous device (TV-ICD), according to the investigators of the ATLAS trial, who presented their...
Findings of the US multicentre cardioneural ablation (CNA) registry were presented during a late-breaking clinical trial session at the Heart Rhythm Society’s 2022 annual meeting (HRS 2022, 29 April–1 May, San Francisco, USA), showing that ablation can be a...
Attune Medical has announced that the first patients have been enrolled in the IMPACT II— Improving Oesophageal Protection During Catheter Ablation for Atrial Fibrillation—study, evaluating the use of the ensoETM in cardiac radiofrequency ablation procedures. Data from this study will...
inHEART has received US Food and Drug Administration (FDA) 510(k) clearance for its inHEART Models software suite that enables 3D visualisation and analysis of anatomical structures for pre-procedural planning and intraprocedural use. With this clearance, inHEART will expand its commercial...
Endotronix has announced data from the SIRONA 2 clinical trial evaluating safety and efficacy of its Cordella pulmonary artery pressure sensor system in New York Heart Association (NYHA) class III heart failure patients. The prospective, multicentre trial met all primary...
Findings of the EAST-AFNET 4 trial, examining the benefit of early rhythm control therapy in patients with newly diagnosed atrial fibrillation (AF), should influence future guidelines for the treatment of AF patients. This was the message of Paulus Kirchhof (Hamburg,...
Results of a study presented at the Heart Rhythm Society’s 2022 annual meeting (HRS 2022, 29 April–1 May, San Francisco, USA) show that the success of intended same day discharge (SDD) improves over time for patients undergoing atrial fibrillation...
Use of an artificial intelligence (AI)-based app using electrocardiogram (ECG) signals recorded with an Apple Watch is able to identify left-ventricular dysfunction, research presented at the Heart Rhythm Society’s 2022 annual meeting (HRS 2022, 29 April–1 May, San Francisco,...
CathVision has announced US Food and Drug Administration (FDA) 510(k) clearance of the ECGenius electrophysiology recording system. ECGenius acquires high-fidelity, low-noise, cardiac electrograms to help electrophysiologists improve the diagnosis and treatment of complex atrial arrhythmias, including atrial fibrillation (AF). Conventional...
Ceryx Medical has raised £3.8m in seed funding which will be used to commercialise its technology and commence the first-in-human clinical study of the cardiac rhythm management device, Cysoni, later this year. The new funding involves Icehouse Ventures, The Development...
The Heart Rhythm Society (HRS) has announced the findings of three clinical trials demonstrating positive outcomes of conduction system pacing (CSP) for patients in need of cardiac resynchronisation therapy (CRT). The studies were presented as late-breaking clinical science at...
Results from a new clinical trial found aggressive blood pressure (BP) control reduced the risk of left-ventricular conduction disease. This study is the first to provide causal evidence that cardiac conduction disease is preventable, according to researchers. Findings were...
Abbott has announced US availability of its Amplatzer steerable delivery sheath, which is used with the company's Amplatzer Amulet left atrial appendage (LAA) occluder to treat people with atrial fibrillation (AFib) who are at risk of ischaemic stroke. For patients...
Medtronic has announced new data from the STROKE AF clinical trial, showing that large and small vessel ischaemic stroke patients who receive short-term or intermittent monitoring using holter monitors and 30-day external monitors may not be optimally managed for...
CathVision has completed patient enrolment in the CathVision ECGenius System clinical evaluation study at the University of Vermont Medical Center (Burlington, USA). The study is the first in the USA to evaluate the safety and technical performance of ECGenius...
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 as chief clinical and regulatory officer, aligning and integrating the company's scientific, medical, clinical research...
The use of high-power, short duration ablation for atrial fibrillation (AF) has the potential to speed up procedural times and increase the number of ablations that can be performed in a day. This is the message of Teresa Strisciuglio (Clinica...
The pandemic saw a boom in the use of remote technologies and telehealth for patient monitoring and management, including for patients with heart failure—and many of these technologies look to have a role in the future, even despite a...
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 spring. AccuRhythm AI applies artificial intelligence (AI) to heart rhythm event data collected by LINQ II,...
Fitbit has received clearance from the US Food and Drug Administration (FDA) for a new photoplethysmography (PPG) algorithm to identify atrial fibrillation (AF). The algorithm will power a new irregular heart rhythm notification feature on Fitbit. In a press release,...
Cardiologs has announced the results of a clinical study showing that its deep learning artificial intelligence (AI) software reduces inconclusive results returned by the latest Apple Watch ECG companion app—Apple ECG 2.0—while maintaining performance (sensitivity and specificity). “Wearable devices, such...
Among the array of remote monitoring and digital arrhythmia management tools on display at the 2022 European Heart Rhythm Association annual meeting (EHRA 2022, 3‒5 April, Copenhagen, Denmark), Boston Scientific showcased its Heart Connect remote support system, which has...
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 occlusion (LAAO) with Abbott’s Amplatzer Amulet and Boston Scientific’s Watchman FLX device. FEops Heartguide is a...
iRhythm Technologies has announced the results of three clinical research studies presented at the American College of Cardiology’s annual scientific sessions (ACC 2022, 2–4 April, Washington DC, USA). According to iRhythm, the evidence further validates the Zio service as a...
Abbott has announced that the US Food and Drug Administration (FDA) has approved the Aveir single-chamber (VR) leadless pacemaker for the treatment of patients in the USA with slow heart rhythms. This marks significant advancement for patient care and...
Screening for atrial fibrillation (AF) should be integrated into flu vaccination and cancer screening programmes, according to a survey of general practitioners (GPs) conducted by the AFFECT-EU project and presented at the 2022 European Heart Rhythm Association annual meeting...
A simple electrocardiogram (ECG) can pinpoint hospitalised COVID-19 patients at high risk of death who might need intensive management, according to the authors of a study presented at the 2022 European Heart Rhythm Association annual meeting (EHRA 2022, 3‒5...
Overweight patients with atrial fibrillation (AF) are more likely to experience a return of the heart rhythm disorder after a corrective procedure than those of normal weight, according to research presented at the 2022 European Heart Rhythm Association annual...
Results of a large-scale, real-world analysis of US Centers for Medicare & Medicaid Services (CMS) data on the rates of guideline adherence and associated mortality in patients with cardiac implantable electronic device (CIED) infection show that only around one...
Use of cardiac magnetic resonance (CMR) may relevant role of CMR in risk stratification for sudden cardiac death after myocardial infarction, to late-breaking research presented at the 2022 European Heart Rhythm Association annual meeting (EHRA 2022, 3‒5 April, Copenhagen,...
Recommendations on the prevention and management of interference caused by medical procedures in patients with implanted electronic cardiac devices has been published today in EP Europace, and presented at the 2022 European Heart Rhythm Association annual meeting (EHRA 2022,...
The “exponential growth” in the use of digital devices for monitoring arrhythmias has led to the development of a new international consensus document. The paper, published today in EP Europace, will also be presented at the 2022 European Heart...
East End Medical has announced the first commercial use of its SafeCross transseptal radiofrequency (RF) puncture and steerable balloon introducer system. The system is designed to provide a predictable and safe solution for performing electrophysiology and structural heart interventions...
The launch of the latest KODEX-EPD cardiac mapping and navigation system is among the features Royal Philips will showcase at the 2022 European Heart Rhythm Association annual meeting (EHRA 2022, 3‒5 April, Copenhagen, Denmark), the company has revealed in...
GE Healthcare and AliveCor have announced a partnership to deliver medical-grade six-lead electrocardiograms (ECGs) taken by patients on an AliveCor KardiaMobile 6L ECG device outside of the hospital setting directly into GE Healthcare’s MUSE Cardiac Management System for physicians...
Researchers have developed a clinical algorithm that distinguishes between treatable sudden cardiac arrest and untreatable forms of the condition. The findings, Journal of the American College of Cardiology: Clinical Electrophysiology, have the potential to enhance prevention of sudden cardiac arrest,...
Black and Hispanic individuals experiencing a cardiac arrest either at home or in public are substantially less likely to receive cardiopulmonary resuscitation (CPR) from a bystander compared to white individuals, according to a study presented at the American College...
Researchers want to leverage the centuries-old art of cutting paper into designs to develop a sensor sheet that can stretch and breathe alongside the skin while collecting electrocardiographic data, according to a press review. In Applied Physics Reviews, the...
Stereotaxis has announced that Poland’s National Institute of Cardiology in Warsaw has established the first robotic electrophysiology programme in the country with Stereotaxis’ Genesis robotic magnetic navigation (RMN) system. The National Institute of Cardiology is the only hospital in...
Research published in the journal BMC Medicine investigates the impact of kidney function in patients on antithrombotic therapy. The study, a post hoc sub-group analysis focusing on recurrent bleeding events in the AFIRE (Atrial Fibrillation and Ischemic Events with Rivaroxaban...
Pulmonary vein-left atrial (PV/LA) volume ratio is a significantly better predictor power for atrial fibrillation (AF) recurrence than LA dimension in patients with normal or mild LA enlargement, with an association between PV/LA volume and the PITX2 gene. This...
A consensus document outlining design principles and outcome definitions for device-based therapies for hypertension has been published in the journal Circulation. The development of the document has been led by the Hypertension Academic Research Consortium (HARC), which aims to create...
Pulsed-field ablation (PFA) and/or radiofrequency ablation (RFA) using a lattice-tip catheter can both isolate pulmonary veins (PVs) and create linear lesions efficiently and safely, with a high degree of lesion durability, and promising freedom from arrythmia recurrence. This was...
DiA Imaging Analysis Ltd, announced today a multi-year agreement with Change Healthcare. Change Healthcare's proven cardiology solutions, along with DiA's AI-based algorithms, will benefit echocardiologists and other imaging specialists by improving the efficiency of routine tasks and the effectiveness...
A new strategy using telehealth to monitor blood pressure at home for several months immediately after a stroke had a positive impact on patient engagement and blood pressure control among people who live in historically under-resourced communities, according to preliminary research presented at...
Hospitals in England are trialling remote monitoring technology from iRhythm Technologies—Zio XT—which is designed to aid the detection of arrhythmias supported by artificial intelligence. Typically patients experiencing symptoms of an arrhythmia would need to go to hospital for 24 hours...
Royal Philips has announced new research evaluating mobile cardiac outpatient telemetry (MCOT) as a first-line diagnostic ambulatory monitoring solution with post-cryptogenic stroke patients. The study determined that a 30-day continuous monitoring program using the Philips BioTel Heart MCOT patch, followed...
As a result of the COVID-19 pandemic, the increasing uptake of paediatric electrophysiology (EP) telehealth services has demonstrated clear ability to deliver healthcare for a pathologically and geographically diverse group of patients, who mostly report satisfaction with the service....
Portable electronic devices containing magnets may inhibit pulse generators for implanted cardiac devices (ICDs) and pacemakers according to new research published in Circulation: Arrhythmia and Electrophysiology. The authors of the research, Corentin Féry (Institute for Medical Engineering and Medical Informatics,...
A recent systematic review and meta-analysis, published in the Journal of Interventional Cardiac Electrophysiology, has deemed same-day discharge following catheter ablation of atrial fibrillation (AF) to be safe and feasible.   According to a recent review, it is common practice...
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 major adverse events at seven days following implant of the device. The SURPASS analysis, which included...
Women remain underrepresented in leading cardiovascular clinical trials, corresponding with underrepresentation and a lack of gender diversity among presenters at scientific meetings, according to a review published in the Journal of the American College of Cardiology (JACC). A previous analysis...
Wearable technology and digital health specialist Activinsights has announced a partnership agreement with the cardiovascular research organisation Cardialysis to promote the use of remote monitoring wearables as a tool for researchers to better understand the daily lifestyles of cardiac...
A review paper published in JACC: Clinical Electrophysiology explores the potential mechanisms linking stress and atrial fibrillation (AF), and the possible uses of stress reduction in the management of the condition. Stress has been linked with poor health outcomes, though...
Historically, catheter ablation has been reserved for atrial fibrillation (AF) patients who have failed to respond to, or tolerate antiarrhythmic drug therapy, electrophysiologist Dhiraj Gupta (Liverpool Heart and Chest Hospital, Liverpool, UK) tells Cardiac Rhythm News. However, he explains,...
Both cryoballoon ablation (CBA) and hot balloon ablation (HBA) are effective treatment options for atrial fibrillation (AF), however, patients treated with HBA are more likely to receive touch-up ablation, with a longer procedure time. This was the main concluding...
Siemens Healthineers has announced the launch of Artis icono biplane—an angiography system with detectors optimised in size for integrated use in the cath lab. The system offers new features for diagnosing and treating cardiac arrhythmia, coronary heart disease, and structural...
Abbott has announced that the US Food and Drug Administration (FDA) has approved an expanded indication for the company’s CardioMEMS HF system to support the care of more people living with heart failure. With the expanded indication, an additional 1.2...
Medtronic has announced that the Freezor and Freezor Xtra cardiac cryoablation catheters are approved by the US Food and Drug Administration (FDA) to treat the growing prevalence of paediatric atrioventricular nodal reentrant tachycardia (AVNRT). AVNRT is the most common form...
Fewer than half of UK citizens are aware of the link between arrhythmia and stroke, while around one in five people with a personal or familial risk of heart disease were unaware of how to check their pulse to...
Cardiologist and researcher Robert Califf has been confirmed as the commissioner of the US Food and Drug Administration (FDA). Califf returns to the role that he held between September 2016 and January 2017, having been confirmed in a vote...
A new timely practice—known as the “1-2-3-4-day” rule—for the administration of direct oral anticoagulants (DOACs) in patients after acute ischaemic stroke or transient ischaemic attack (TIA) is deemed feasible to decrease the risk of recurrent stroke, systemic embolism, and...
Boston Scientific has announced the close of its acquisition of Baylis Medical Company, a company that offers advanced transseptal access solutions as well as guidewires, sheaths and dilators used to support catheter-based left-heart procedures. “The close of this acquisition allows...
Vektor Medical has announced that the University of California, San Diego Health (UCSD, San Diego, USA) is the first hospital system to offer the vMap arrhythmia mapping system. The recently US Food and Drug Administration (FDA)-approved technology identifies potential arrhythmia...
CoreMap has announced the closure of a US$3 million series A milestone financing, with a US$20 million series B financing, which includes a diverse group of strategic, institutional, venture, and individual partners. Pierre Jaïs of the Electrophysiology and Heart Modeling...
A collaboration between Ceryx Medical Limited and the scientists at the Auckland Bioengineering Institute (ABI) and the Universities of Bath and Bristol, have developed technology that they claim, could improve the outlook for patients with serious heart conditions. Ceryx Medical's...
atHeart Medical has announced that it has received US Food and Drug Administration (FDA) approval for the start of the second phase of its ASCENT ASD US investigational device exemption (IDE) pivotal trial, evaluating the safety and efficacy of...
The placement of an interarterial shunt device—the Corvia atrial shunt (Corvia Medical)—did not reduce the total rate of heart failure events in a population of patients with heart failure with preserved or mildly reduced ejection fraction (HFpEF or HFmrEF). This...
Abbott has announced the first patient implants of a dual-chamber leadless pacemaker system as part of its AVEIR DR i2i pivotal clinical study. The implant of Abbott's investigational Aveir dual-chamber leadless pacemaker represents a technological milestone for leadless pacing...
BioCardia has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CardiAMP cell therapy system for the treatment of heart failure. CardiAMP cell therapy uses autologous bone marrow cells delivered to the heart...
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 study published in the Journal of Invasive Cardiology, who concluded that the strategy is safe,...
AliveCor has announced the launch of KardiaMobile Card—an electrocardiogram (ECG) device the size of a standard credit card. “After disrupting traditional ECG monitoring with our game-changing Kardia platform, we have now achieved the unprecedented milestone of creating the first-ever credit-card-sized...
Use of temperature-controlled ablation for the treatment of atrial fibrillation (AF) is effective and highly efficient, according to Jose Osorio—the director of electrophysiology at Grandview Medical Center in Birmingham, Alabama, USA. His comments follow the completion of a US-based...
The US Food and Drug Administration (FDA) has issued two final guidances providing recommendations for including patient perspectives in medical device clinical studies.   As per an FDA press release, the finalised version of the first of these two guidance...
Royal Philips has announced the introduction of a full-service, at-home, 12-lead electrocardiogram (ECG) solution for use in decentralised clinical trials. The clinical-grade solution is the most advanced patient-centric ECG offering within the company’s cardiac monitoring portfolio, pairing data readings...
A recent study has demonstrated 100% pulmonary vein isolation (PVI) using only pulsed field ablation (PFA), resulting in no PFA-related serious adverse events. This was the concluding finding of the PULSED AF (Pulsed-field ablation to irreversibly electroporate tissue and...
Contact-force (CF)-guided ablation to treat typical atrial flutter does not reduce recurrent atrial arrhythmia at 12 months follow-up, in comparison to ablation blinded for contact force. This was the main conclusion of a randomised controlled trial (RCT), findings of...
Acute alcohol consumption is associated with a higher risk of atrial fibrillation (AF), a study published in Nature Cardiovascular Research has concluded The study is the first to show an association between increased drinking and hospital visits for AF in...
Royal Philips is supporting the American Heart Association’s (AHA’S) effort to generate awareness among cross-disciplinary specialties and improve survival rates from cardiovascular implantable electronic device (CIED) infections. With the support of Philips, the American Heart Association’s national CIED infection initiative...
According to a press release, AtriAN Medicals clinical data from the Neural atrial fibrillation (AF) study was presented by Vivek Reddy (Mount Sinai Hospital, New York, USA) at this year's renowned annual AF symposium 2022 (13—15 January, New York...
MicroPort CRM has recently received the pharmaceuticals and medical devices agency (PMDA) Japanese regulation agency approval for the Alizea range of portable pacemakers. The devices are equipped with bluetooth technology for streamlined remote monitoring when paired with MicroPort CRM's...
Abbott has received clearance from the US Food and Drug Administration (FDA) for the EnSite X EP system with EnSite Omnipolar Technology (OT), a new cardiac mapping platform available in the USA and across Europe that is designed to...
Medtronic has received approval from Japan's Ministry of Health, Labor and Welfare for the sale and reimbursement of the Micra AV Transcatheter Pacing System (TPS), and the company will launch the product this month. This approval expands the number of...

Medtronic to acquire Affera

Medtronic has announced that it has entered into an agreement to acquire medical technology company Affera. Affera designs and manufactures cardiac mapping and navigation systems and catheter-based cardiac ablation technologies, including a differentiated, focal pulsed field ablation (PFA) solution, for...
Khaldoun Tarakji, associate section head of cardiac electrophysiology at the Heart, Vascular, and Thoracic Institute at Cleveland Clinic (Cleveland, USA) has joined Medtronic as vice president and chief medical officer (CMO) of the company's Cardiac Ablation Solutions (CAS) Operating...
The National Institute for Health and Care Excellence (NICE) has issued Medical Technologies Guidance (MTG) recommending KardiaMobile (AliveCor) as an option for detecting atrial fibrillation (AF) in patients with suspected paroxysmal AF, who present with symptoms such as palpitations...
Endotronix has announced that the US Food and Drug Administration (FDA) has granted approval for an amendment to the company's PROACTIVE-HF study, a pivotal Investigational Device Exemption (IDE) trial investigating the Cordella Pulmonary Artery (PA) Pressure Sensor, shifting the...
Adagio Medical has announced first-in-human cases of pulsed field cryoablation (PFCA) for the treatment of atrial fibrillation (AF). The cases were performed at Medicover Hospital, Warsaw, Poland by Pawel Derejko, head of the Department of Cardiology at Medicover and Atul...
Volta Medical has announced the introduction of VX1 artificial intelligence (AI) software at three US hospitals. New York Presbyterian Queens, Northwell Health’s Lenox Hill Hospital both in New York, and Ascension St. Vincent’s Riverside, Jacksonville, have been named as...
Doctors at St David's Medical Center in Austin, USA recently implanted a new neurostimulator technology in patients to help treat advanced heart failure—and are among the first physicians in the USA to do so, according to a press release. The...
Affera has announced that the first patient was treated in the recently approved SPHERE PerAF trial, a US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal randomised trial, to evaluate the safety and effectiveness of the Affera...
FAST BioMedical has announced the publication of additional results from the EMPAKT CHF (Estimating versus Measuring Plasma Volume and Kidney Function in Acute Decompensated Congestive Heart Failure) ­clinical trial in the European Society of Cardiology (ESC) Heart Failure journal....
Kardium has announced the completion of successful first-in-human (FIH) procedures with the Globe pulsed field system. Vivek Reddy of Mount Sinai Hospital (New York, USA) and Petr Neužil of Na Homolce Hospital (Prague, Czech Republic), performed the procedures in Prague,...
Implicity has announced US Food and Drug Administration (FDA) clearance for a novel medical algorithm that analyses ECG data from implantable loop recorders (ILRs). “This is an important step for Implicity as we expand in the US market,” said Arnaud...
LifeTech Scientific Corporation has announced that it has extended its agreements with Medtronic to further the strategic collaboration on the HeartTone domestic pacemaker project and to start the collaboration on domestically-made MRI-conditional pacemakers. Together with MRI-conditional leads, these products...
Stereotaxis has announced the publication of the results of a prospective, multicentre study comparing the incidence of silent cerebral embolism (SCE) in atrial fibrillation (AF) patients undergoing robotic cardiac ablation or manual in Frontiers in Cardiovascular Medicine. The study evaluated...
New research suggests that implantable cardioverter defibrillators (ICDs) are not used as frequently for females and patients of colour, despite the increased use of ICDs in the management of patients with hypertrophic cardiomyopathy (HCM), over recent decades.   In patients with HCM,...
Royal Philips has announced an expansion of its ultrasound portfolio with new imaging tools and features for cardiology, designed to “increase diagnostic confidence and workflow efficiency”. Philips will be showcasing these developments through its participation in the EuroEcho 2021...
SyMap Medical has announced the completion of a financing round which will be used to accelerate global clinical trials for the company’s renal mapping and selective renal denervation systems. The financing round of nearly US$100 million was led by Primavera...
One in 10 junior doctors training to be cardiologists in the UK say they have been bullied, the results of a survey published online in the journal Heart indicate. Women and those who qualified in medicine outside the UK...
Restore Medical has announced preliminary results of the first-in-human clinical trial of ContraBand, a breakthrough treatment for patients suffering from congestive heart failure. The minimally-invasive, catheter-delivered implants are used to treat patients with chronic left ventricular failure. ContraBand has been...
Boston Scientific has announced the start of the MODULAR ATP clinical trial to evaluate the safety, performance and effectiveness of the mCRM modular therapy system. The mCRM system consists of two cardiac rhythm management (CRM) devices intended to work...
Persistent opioid use following a cardiac implantable electronic device (CIED) procedure is common, according to a study published in Circulation, which reports that 12% of patients receiving a CIED are consistently using pain medication in the months after the...
Canon Medical has announced the introduction of the Precise IQ Engine (PIQE) deep-learning reconstruction (DLR) and SilverBeam filter. PIQE, which Canon describes as super-resolution deep-learning reconstruction technology for cardiac computed tomography (CT) scans, delivers “exceptional” cardiac CT image quality by...
Acutus Medical has announced the initiation of AcQForce PFA-CE, a clinical study that will evaluate the safety and performance of the company’s focal force sensing pulsed field ablation (PFA) catheter and system in combination with its novel noncontact 3D...
Cardiologs announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to use its AI-powered cardiac diagnostics platform for paediatric cardiology. The expanded authorisation was granted based on an analysis of the company's improved deep...
The advent of pulsed field ablation (PFA) will revolutionise the treatment of atrial fibrillation (AF), Tom de Potter (Aalst, Belgium) tells Cardiac Rhythm News, discussing the future of the treatment of the condition. PFA utilises a controlled electric field to...
European Society of Cardiology (ESC) guidance for the diagnosis and management of cardiovascular disease during the COVID-19 pandemic has been published in the European Heart Journal. The guidance brought together a large number of key opinion leaders at the outset...
Cardialen has received approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) to begin a clinical trial of its Multipulse Therapy (MPT) to treat paroxysmal and persistent atrial fibrillation (AF). MPT is delivered as...
Women diagnosed with breast cancer are significantly more likely to develop atrial fibrillation (AF) compared to women without cancer, according to research published in the European Heart Journal. These patients have a three-fold increased risk of death from either heart...
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; virtual), suggest that the consumer fitness tracking watch, Fitbit, was capable of detecting undiagnosed atrial...
HeartVista has received US Food and Drug Administration (FDA) 510(k) clearance to deliver its AI-assisted One Click magnetic resonance imaging (MRI) acquisition software on Siemens Healthineers MRI scanners. The use of cardiac MRI, also known as cardiac magnetic resonance (CMR),...

What to expect from AHA 2021

Ahead of the American Heart Association’s 2021 annual scientific sessions (AHA 2021, 13–15 November, virtual), Cardiac Rhythm News speaks to the meeting’s programme committee chair Manesh Patel (Duke University School of Medicine, Durham, USA) about some of the highlights...
Data from the global Leadless II IDE study evaluating the Aveir (Abbott) leadless pacemaker in patients with certain abnormal heart rhythms show that the device met its prespecified primary safety and efficacy endpoints . The findings were presented today in...
Adults with type 1 or type 2 diabetes and atrial fibrillation (AF) are less likely to notice irregular heartbeat symptoms, more likely to have a lower quality of life (QoL), and experience more co-existing health conditions than people with...
Caption Health and Ultromics have announced a strategic partnership to accelerate cardiovascular disease detection and treatment for more patients in more accessible care settings. Together, the companies will jointly offer the Caption AI software platform alongside Ultromics’ EchoGo deep...
Vektor Medical has announced US Food and Drug Administration (FDA) 510(k) clearance for its novel computational electrocardiogram (ECG) mapping system, vMap. vMap is designed to map potential arrhythmia sources associated with stable or unstable arrhythmias anywhere in the heart—including all...
Patients who went into cardiac arrest in the cardiac cath lab were more likely to survive to hospital discharge than those who had a cardiac arrest in the intensive care unit (ICU), yet less likely to survive than those...
Medtronic has announced its ambition to achieve net zero carbon emissions by fiscal year 2045 across its operations and value chain to accelerate efforts to combat climate change. The announcement comes amidst the 2021 United Nations Climate Change Conference...
Royal Philips has signed an agreement to acquire Cardiologs, a developer of cardiac diagnostics using artificial intelligence (AI) and cloud technology. Cardiologs will further strengthen Philips’ cardiac monitoring and diagnostics offering with innovative software technology, electrocardiogram (ECG) analysis and...
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 (Abbott) and Watchman FLX (Boston Scientific) left atrial appendage closure (LAAC) devices, show similar rates...
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 non-valvular atrial fibrillation (AF) at long-term follow-up. These are four-year findings of the PRAGUE-17 clinical trial,...
South Korean artificial intelligence (AI) developer Vuno has announced that the Korean Ministry of Food and Drug Safety (KFDA) has designated the company's AI-based electrocardiogram (ECG) analysis software Vuno Med-DeepECG as a breakthrough device. Using deep learning, the software...
Researchers from Massachusetts General Hospital (MGH, Boston, USA) have reported the detection and characterisation of thrombosis using fibrin-targeted positron emission tomography and magnetic resonance in a first-in-human study published in JACC: Cardiovascular Imaging. Atrial fibrillation (AF) can cause clots to...
Research presented at the American College of Rheumatology’s annual meeting (ACR Convergence, 3–9 November, virtual) shows that hydroxychloroquine does not appear to be associated with QTc interval prolongation, an irregularity of the electrical activity of the heart that places...
A pragmatic clinical trial—CHANGE AFib—will determine whether early treatment with the antiarrhythmic drug dronedarone improves cardiovascular and long-term outcomes in patients presenting with first-detected atrial fibrillation (AF). The trial represents a collaboration between the American Heart Association (AHA) and...
CathVision has announced the first patient enrolments in the PVISION multicentre clinical study, investigating the automated assessment of pulmonary vein isolation (PVI) using the company's artificial intelligence (AI) algorithm, a PVI analyser, in combination with the ECGenius system, CathVision's...
An artificial intelligence (AI)-based computer algorithm created by researchers at the Mount Sinai Health System (New York, USA) has been able to learn how to identify subtle changes in electrocardiograms (ECGs) to predict whether a patient was experiencing heart...
Ethnic and racial minority cardiologists report career satisfaction but face professional discrimination and exclusion. This was the main finding of the American College of Cardiology (ACC) professional life survey, published in the Journal of the American College of Cardiology...
Stereotaxis has announced publication of a study in the International Journal of Cardiology: Heart & Vascular demonstrating superior safety and efficacy of Stereotaxis’ robotic technology to treat atrioventricular reentry tachycardia (AVRT) and atrioventricular nodal reentry tachycardia (AVNRT) in paediatric...
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 to closing adjustments, will see Baylis Medical Company and its cardiology products transition to Boston...
Medtronic has announced the publication of a study demonstrating, through the use of a continuous rhythm monitoring device, that atrial fibrillation (AF) is directly and transiently associated with ischaemic stroke. The findings were published online in JAMA Cardiology. This retrospective...
Haemonetics Corporation has announced that the Vascade MVP venous vascular closure system is has received a US Food and Drug (FDA) indication for same-day discharge following atrial fibrillation (AF) ablation. The same-day discharge labelling was granted following the conclusion of...
The US Food and Drug Administration (FDA) has informed healthcare providers of recent information about the potential for differences in procedural outcomes between women and men undergoing implant of a left atrial appendage occlusion (LAAO) device. The FDA is evaluating...
Abbott has announced that the US Food and Drug Administration (FDA) has approved the company's Amplatzer Talisman PFO Occlusion System to treat people with a patent foramen ovale (PFO)—a small opening between the upper chambers of the heart—who are...
Biosense Webster, part of the Johnson & Johnson Medical Devices Companies has announced post-approval procedures were successfully performed with the Heliostar radiofrequency balloon ablation catheter at sites across Europe. In Europe, the Heliostar Balloon Catheter is indicated for use...
Benjamin D’Souza, assistant professor of Medicine at the University of Pennsylvania, cardiac electrophysiologist at Penn Presbyterian Medical Center, Philadelphia, USA, discusses the recent developments in robotics in the electrophysiology (EP) lab. The two main criticisms of the use of robotics...
The Heart Rhythm Society (HRS) has announced that its cardiovascular digital health conference—HRX—has been rescheduled to September 2022. The event had been due to take place in San Diego, USA, over 2–4 December 2021. In a statement issued late last...
Specific and dynamic changes on electrocardiograms (ECGs) of hospitalised patients with COVID-19 or influenza can help predict a timeframe for worsening health and death, according to a new study published in the American Journal of Cardiology. The study, carried...
Continuous heart rhythm monitoring—with anticoagulation if atrial fibrillation (AF) is detected—does not prevent strokes in those at risk. That is the finding of the LOOP study, presented during a Hot Line session at the European Society of Cardiology’s 2021...
Ablation plus cardiac resynchronisation therapy (CRT) is superior to pharmacological rate control in reducing mortality in severely symptomatic permanent atrial fibrillation (AF) patients with a narrow QRS, according to late breaking research presented in a Hot Line session at...
Image-guided fibrosis ablation in addition to pulmonary vein isolation (PVI) does not improve ablation success rates compared to PVI alone in patients with persistent atrial fibrillation (AF), according to an intention-to-treat analysis presented in a Hot Line session at...
The Arrhythmia Alliance’s 2021 Heart Rhythm Congress (A-A HRC 2021 3–6 October, virtual) returns for its second ever digital edition, which will see more than 250 world heart rhythm specialists deliver more than 200 hours of educational content. In recognition...
Galaxy Medical announced today the initiation of the SPACE-AF study with enrolment of the first two patients at Southlake Regional Health Centre in Newmarket, Canada.  In the study, the Centauri pulsed electric field (PEF) ablation system will be used to...
QardioDirect, the all-inclusive service for remote patient monitoring (RPM) from Qardio, now includes ambulatory cardiac monitoring to help diagnose atrial fibrillation (AF) along with a range of other arrhythmias. Multiple short duration recordings can identify symptomatic and asymptomatic periods of...
VitalConnect has announced the launch of a new version of VistaCenter for cardiac and remote patient monitoring. This new version brings updates including simplified patient intake, live patient census views, custom notification profiles and report delivery—all designed to streamline...
Medtronic has announced a pilot programme with Mpirik to address disparities in care associated with the prevention of sudden cardiac arrest (SCA), a condition in which the heart suddenly and unexpectedly stops beating. SCA is caused by a disturbance...
Zoll Medical and Itamar Medical have announced that the two companies signed a definitive agreement under which Zoll Medical will acquire all outstanding ordinary shares of Itamar Medical for a total value of approximately US$538 million. Itamar Medical is focused...
Biotronik has announced the first observational results of the CERTITUDE registry, documenting real-world clinical outcomes of patients in the USA who use implantable loop recorders (ILR), pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronisation therapy (CRT-D) devices that have Biotronik...
Stereotaxis and Shanghai Microport EP Medtech have announced a broad collaboration to advance technology innovation and commercial adoption of robotics in electrophysiology in China. The agreement brings together MicroPort EP’s commercial and product leadership in China’s electrophysiology market with Stereotaxis’...
Bhargav Vemulapalli, Shreya Srivastava and John Kassotis (New Brunswick, USA) review the potential use of antibiotic-eluting envelopes (ABEs) based on available clinical data, while underscoring the need for standardised guidelines related to antibiotic prophylaxis. Infections associated with cardiac implantable electronic...
AliveCor has announced the results of what it describes as the largest study to assess the reliability of the detection of atrial fibrillation (AF) through commercially available personal ECG devices, in which its KardiaMobile 6L device was found to...
Cardiomatics, the cloud AI tool that allows any trained medical staff to carry out electrocardiogram (ECG) analysis, has raised US$3.2 million in seed funding led by KAYA, the Central and Eastern European VC which has backed companies including Rohlik,...
Edoxaban is noninferior to warfarin and its analogues for adverse clinical events in patients with atrial fibrillation after transcatheter aortic valve implantation (TAVI), new research has found. Findings of the ENVISAGE-TAVI AF study, which were published in the New England...
Medtronic has announced new data from the Micra Coverage with Evidence Development (CED) study, which showed the Micra transcatheter pacing system (TPS) was associated with a 38% reduction in reinterventions and a 31% reduction in chronic complications at two...
Biosense Webster, part of the Johnson & Johnson Medical Devices Companies, has announced the presentation of data from the inspIRE clinical trial at the European Society of Cardiology’s 2021 congress (ESC 2021, 27–30 August, virtual). inspIRE is a prospective, multicentre,...
The European Society of Cardiology (ESC) Guidelines on cardiac pacing and cardiac resynchronisation therapy (CRT) have been published online in European Heart Journal. The use of pacemakers continues to grow as populations worldwide are living longer. It is estimated that...
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 (LAA) occluder with the Watchman (Boston Scientific) device to treat patients with atrial fibrillation (AF)...
Abbott has announced results of the landmark GUIDE-HF clinical trial, a 1,000 patient randomised study designed to assess the benefits of the CardioMEMS HF System in people living with NYHA Class II, III and IV heart failure. Data adjusted for...
The world’s first feasibility study has found that drones can be used to deliver defibrillators to people with suspected cardiac arrest in the community. The research is presented at the European Society of Cardiology’s 2021 congress (ESC 2021, 27–30...
The European Society of Cardiology (ESC) Guidelines for the diagnosis and treatment of acute and chronic heart failure are published online today in European Heart Journal. This was the first ESC Guideline to include patients as full members of...
A six-month exercise programme helps maintain normal heart rhythm and reduces the severity of symptoms in patients with atrial fibrillation (AF), according to late-breaking research to presented this week at the European Society of Cardiology’s 2021 congress (ESC 2021,...
Ultromics, a developer of AI enabled cardiovascular imaging solutions, has announced that it has raised US$33 million in a Series B funding round. The round was led by the Blue Venture Fund with participation from Optum Ventures, GV, and...
The US Food and Drug Administration (FDA) has granted breakthrough device designation to Abiomed’s Impella ECP expandable percutaneous heart pump. The designation means the FDA will prioritise Impella ECP’s regulatory review processes including design iterations, clinical study protocols and...
CardioNXT has received marketing clearance from the US Food and Drug Administration (FDA) for the platform technology comprised of the iMap 3D Navigation & Mapping system, Activate software, Sensor Enabled Axis Patient Patches, and MultiLink sensor enabled catheter. The CardioNXT...
Biotronik has announced the results from a new study published in EP Europace this week confirming that heart failure (HF) decompensation can be predicted early when monitored using an algorithm that combines existing remote monitoring trends and baseline risk...
People who work night shifts are at increased risk of developing atrial fibrillation (AF), according to research published in the European Heart Journal. The study is the first to investigate the links between night shift work and AF, and uses...
Abbott has announced that the US Food and Drug Administration (FDA)  has approved the company's Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation (AF) who are at risk of ischaemic stroke. The device offers immediate...
Acutus Medical has received US Food and Drug Administration (FDA) and CE mark clearance for its suite of software upgrades known collectively as AcQMap 8. The upgrades introduce new mapping algorithms into Acutus’ foundational technology, the AcQMap 3D imaging...
Long-term continuous electrocardiogtraphy (LT-ECG), coupled with oversight by a physician, significantly outperforms algorithm-dependent mobile cardiac telemetry (MCT) in the detection of significant arrhythmias according to the findings of a study presented during a late-breaking trial session at the 2021...
Caption Health has announced that the Centers for Medicare and Medicaid Services (CMS) have approved new technology add-on payments (NTAP) for the Caption Guidance AI-based software platform for Medicare patients receiving in-patient care. Cases eligible for NTAP will have a...
Women remain underrepresented in cardiovascular clinical trials despite initiatives to ensure broader inclusivity. This is according to two reports, both published in the last week, suggesting that lack of representation may limit availability of treatment data for combating cardiovascular...
The challenge of rapid detection and diagnosis of atrial fibrillation (AF) has been made even harder with the onset of the COVID-19 pandemic, and the resulting disruption to appointments and restrictions of access to healthcare services. Against this backdrop,...
Economic analyses from the WRAP-IT study, sponsored by Medtronic, demonstrate the Tyrx cardiac absorbable antibacterial envelope’s (Tyrx Envelope) cost effectiveness in European markets for patients at increased risk of infections. This follows the publication of a study in Heart Rhythm...
Rhythm control therapy offers a clinical benefit when initiated within one year of a diagnosis of atrial fibrillation (AF) in patients with signs or symptoms of heart failure, a sub-analysis of the EAST–AFNET 4 trial has concluded. The findings were...
A new analysis of the CABANA (Catheter ablation versus antiarrhythmic drug therapy for atrial fibrillation) suggests that catheter ablation offers positive economic outcomes compared to drug therapy for the treatment of atrial fibrillation (AF). This is according to the...
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 used as an early first-line treatment for patients with structural heart disease. The PAUSE-SCD trial is...
Use of direct oral anticoagulants (DOACs) in patients undergoing ventricular tachycardia radio frequency ablation (RFA) is associated with a reduced risk of transient ischaemic attack or stroke, and asymptomatic, magnetic resonance imaging (MRI) detected cerebrovascular event. This is according to...
Abbott has announced the US launch of Jot Dx, the company’s latest insertable cardiac monitor (ICM). In a press release, Abbott said that the Jot Dx ICM gives clinicians and hospitals control of how they manage the flow of...
Medtronic has announced US Food and Drug Administration (FDA) clearance for two AccuRhythm AI algorithms for use with the LINQ II insertable cardiac monitor (ICM). The algorithms address the two most common ICM false alerts—atrial fibrillation (AF) and asystole. AccuRhythm...
AliveCor and Acutus Medical will collaborate to assess the integration of data collection tools across the cardiology continuum of care, which the companies say may help guide decision making in the management of cardiac arrhythmia patients. The collaboration includes a...
Angel Medical Systems (AngelMed) has announced the first commercial implantation and US launch of its The Guardian device. The procedure marks the Guardian's first use following its recent US Food and Drug Administration (FDA) approval. Indicated for acute coronary...
Affera has announced the first-in-human use of its circumferential pulmonary vein isolation (PVI) pulsed field ablation (PFA) catheter, SpherePVI. The work was conducted as part of a multicentre first-in-human study designed to evaluate the safety and effectiveness of the SpherePVI...
MicroPort Cardiac Rhythm Management (CRM) has entered into definitive agreements in connection with its Series C financing with total investment proceeds of US$150 million. Hillhouse Capital Group and MicroPort will co-lead the Series C investment and will invest US$20 million...
Medtronic has announced new data from the WRAP-IT study published in Heart Rhythm, which it said demonstrate a significantly lower infection risk for patients who develop haematomas after cardiac implantable electronic devices (CIEDs) when the Tyrx absorbable antibacterial envelope...
People who made even small increases in their daily physical activity levels after receiving an implantable cardioverter defibrillator (ICD) experienced fewer incidences of hospitalisation and had a decreased risk of death, according to research published in Circulation: Cardiovascular Quality...
There is no evidence that moderate coffee consumption can cause cardiac arrhythmia, according to the authors of a prospective, population-based community cohort study, findings of which were published this week in JAMA Internal Medicine. According to authors Eun-jeong Kim (University...
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 (LAAC) device for patients with non-valvular atrial fibrillation (NVAF) have shown that patients implanted with...
Ancora Heart has closed US$80 million in equity financing, with the funds to be used to accelerate the CORCINCH-HF pivotal clinical study of the AccuCinch ventricular restoration system. The device is designed to treat patients who have symptomatic heart...
The authors of research published in JACC: Clinical Electrophysiology claim that their findings will help physicians to identify, treat and prevent atrial fibrillation (AF) in patients with hypertrophic cardiomyopathy (HCM). The research, led by Christopher Kramer the chief of the...
atHeart Medical has announced the successful treatment of the first five patients in its ASCENT ASD US Investigational Device Exemption (IDE) pivotal trial. This study, the company's first in the USA, will evaluate the safety and efficacy of the...
AliveCor has today announced the receipt of 510(k) clearance from the US Food and Drug Administration (FDA) for healthcare professionals to use the KardiaMobile 6L device to calculate patients' QTc interval. This FDA action follows the enforcement policy for...
East End Medical has announced it has received US Food and Drug Administration (FDA) clearance for the company's SafeCross transseptal radiofrequency (RF) puncture & steerable balloon introducer system. The three-in-one system, which includes a steerable introducer sheath with an...
Among racial or ethnic minority patients enrolled in the North American cohort of the CABANA (Catheter ablation versus antiarrhythmic drug therapy for atrial fibrillation) trial, catheter ablation significantly improved major clinical outcomes compared with drug therapy. This is according...
 Fred Kusumoto (Jacksonville, USA), current president of the Heart Rhythm Society (HRS), sits down with Cardiac Rhythm News to discuss the upcoming Heart Rhythm 2021 meeting which, for the first time, will be a hybrid event consisting of both...
Adagio Medical has announced successful first-in-human use of ultra-low temperature cryoablation (ULTC) for the treatment of monomorphic ventricular tachycardia (VT). The two-hour mapping and ablation procedure was performed by Tom De Potter, associate director, Cardiovascular Center Department of Cardiology, Electrophysiology...
Royal Philips has announced the first procedure using its real-time 3D intracardiac echocardiography (ICE) catheter. The left atrial appendage occlusion (LAAO) procedure was carried out by Mohamad Adnan Alkhouli (Mayo Clinic, Minnesota, USA). Used with Philips Premium Cardiology Ultrasound...
The risk of heart damage from COVID-19 infection is far greater than that from receiving a dose of the messenger RNA (mRNA) vaccine, according to the authors of a retrospective case series published in JAMA Cardiology. Researchers from Mayo Clinic...
Boston Scientific has exercised its option to acquire the remaining shares of Farapulse. The acquisition will complement the existing Boston Scientific electrophysiology portfolio to include the Farapulse Pulsed Field Ablation (PFA) system—a non-thermal ablation system for the treatment of...
Medtronic has announced the initiation of DEFINE AFib, an app-based research study which aims to address unanswered questions around atrial fibrillation (AF) burden and its impact on patient outcomes, quality of life, and healthcare utilisation. The study will use...
Angel Medical Systems (AngelMed) has announced US Food and Drug Administration (FDA) approval of the second-generation AngelMed Guardian device. The AngelMed Guardian system is an implantable cardiac detection monitor and patient-warning system for acute coronary syndrome (ACS) events, including...
The American Heart Association (AHA) has this week issued a scientific statement on the management of atrial fibrillation (AF) in patients with heart failure and reduced ejection fraction (HFrEF). Published in Circulation: Arrhythmia and Electrophysiology, the statement reviews available evidence...
CardioFocus has announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the company's HeartLight X3 System for marketing in Japan. The HeartLight X3 System is CardioFocus' catheter ablation technology for controlled and consistent pulmonary vein...
Medtronic has received US Food and Drug Administration (FDA) expanded approval for the Arctic Front family of cardiac cryoablation catheters for the treatment of recurrent symptomatic paroxysmal atrial fibrillation (AF) as an alternative to antiarrhythmic drug (AAD) therapy as...
The Heart Rhythm Society (HRS) has announced the appointment of Simintha Esson as its new chief strategy officer (CSO). In this role, Esson is responsible for developing and implementing strategies to support the organisation’s short- and long-term business development initiatives....
The president of the European Society of Cardiology (ESC) has called for greater awareness of the signs of cardiac arrest and how to respond, following the collapse of Danish footballer Christian Eriksen, during a European Championship match this week. Eriksen,...
Imperial College Healthcare NHS Trust (London, UK) is working with remote healthcare developer, Luscii, to provide an at-home monitoring platform to support patients with heart failure. In its initial phase, the Luscii platform has been rolled out to a distinct...
MicroPort CRM has announced the European launch of Alizea and Borea pacemakers after receiving the CE mark under the new Medical Device Regulation. The devices are equipped with Bluetooth technology for streamlined remote monitoring when paired with the SmartView...
Robert Kowal is the chief medical officer of the Cardiac Rhythm businesses at Medtronic. In this interview he shares his views and experiences on the role that remote monitoring has taken in patients’ lives, both in the past and...
A campaign by Arrhythmia Alliance to DETECT atrial fibrillation (AF)—the most common type of arrhythmia—found that 6% of people aged 65 or older attending a COVID-19 vaccination centre had “possible AF”. The result supports previous findings that the incidence...
Among patients with both heart failure and atrial fibrillation (AF), treatment strategies focused on rhythm control, using catheter ablation, and those focused on rate control, using drugs and or a pacemaker, showed no significant differences in terms of death...
A new physiological measurement of heart function could improve survival for people with heart failure by identifying high-risk patients who require tailored treatments, a study published in the journal Heart, Lung and Circulation suggests. The study is the first to...
GE Healthcare is collaborating with the American College of Cardiology (ACC) through support of and participation in the ACC’s Applied Health Innovation Consortium for the purpose of building a roadmap for Artificial Intelligence (AI) and digital technology in cardiology...
Medtronic has announced clinical trial results from the STROKE AF trial demonstrating the superiority of the Reveal LINQ insertable cardiac monitor (ICM) to detect abnormal heartbeats, otherwise known as atrial fibrillation (AF), in both large and small vessel stroke...
Abbott has announced it has received CE mark and Health Canada approval for its Amplatzer steerable delivery sheath, which is used with the company's Amplatzer Amulet left atrial appendage (LAA) occluder. Now available in Europe and Canada, the device...
Medtronic is stopping the distribution and sale of the Medtronic HVAD system. This morning, the company notified physicians to cease new implants of the HVAD System and transition to an alternative means of durable mechanical circulatory support. Medtronic also announced...
Siemens Healthineers has announced that it has received CE Mark for the AcuNav Volume ICE (intracardiac echocardiography) catheter, an imaging guide that provides real-time, wide-angle visualisation of heart anatomy during structural heart and electrophysiology procedures. “The AcuNav Volume ICE catheter...
Abiomed has acquired preCARDIA, developer of a proprietary catheter and controller to expand options for patients with acute decompensated heart failure (ADHF). The preCARDIA system is designed to rapidly treat ADHF-related volume overload by reducing cardiac filling pressures and...
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 part of its remote patient monitoring offerings with a new digital service that allows cardiologists...
Physical activity that conforms to medical and health association guidelines is associated with a lower risk of atrial fibrillation (AF) and stroke, according to a study by analysing the activity of nearly 100,000 individuals equipped with wrist-worn accelerometers to...
The European Union (EU) Medical Devices Regulation (MDR) takes effect from today (26 May 2021). The Regulation revises quality and safety standards and the range of regulated devices and was first initiated in May 2017, with an initial three-year transition...
iRhythm Technologies has announced two US Food and Drug Administration (FDA) 510K clearances—one for a new and improved design of its flagship monitor and a second for updated artificial intelligence (AI) capabilities. The new Zio monitor is designed to significantly...
Cardiomatics and the Medical University of Warsaw, Warsaw, Poland are developing a tool for automatic assessment, analysis, and interpretation of electrocardiographic signals (ECG) from paediatric patients. The Cardiomatics Junior Project is a direct response to the identified lack of ECG...
The US Food and Drug Administration (FDA) has issued advice to patients with implanted devices such as pacemakers or implantable defibrillators to take precautions against the risk of magnetic interference from smartphones and smart watches. According to the FDA, some...
The proportion of cardiologists reporting burnout has nearly doubled during the COVID-19 pandemic, according to research presented at the American College of Cardiology’s 70th Annual Scientific Session (ACC.21, 15–17 May, virtual). This was among the key findings of the...
Transcatheter left atrial appendage occlusion (LAAO) with a Watchman (Boston Scientific) device was associated with a low rate of stroke at one year, even among older patients with atrial fibrillation (AF) who faced a high risk for stroke or...
Patients with an elevated risk of stroke due to arrhythmia or atrial fibrillation (AF), were much less likely to suffer a stroke after undergoing heart surgery if doctors concurrently performed left atrial appendage occlusion (LAAO), according to the results...
An electrocardiogram (EKG)-based artificial intelligence (AI) algorithm based can enable the early diagnosis of low ejection fraction in patients in routine primary care, according to research published in Nature Medicine. The ECG AI-Guided Screening for Low Ejection Fraction—EAGLE—trial set out...
Pulmonary vein isolation (PVI) with a “single-shot” pulsed-field ablation (PFA) catheter results in excellent PVI durability and acceptable safety with a low one-year rate of atrial arrhythmia recurrence in paroxysmal atrial fibrillation (AF) patients, according to data pooled from...
Acutus Medical has announced CE mark approval for a broad suite of electrophysiology (EP) products including the AcQCross family of universal transseptal crossing devices, the next generation AcQGuide MAX and VUE large bore delivery sheaths and the next generation...
Discrimination and harassment are a common experience among those working in cardiology, according to the findings from a global survey carried out by the American College of Cardiology (ACC), which have been published in the Journal of the American...
Galaxy Medical (Galaxy) and Japan Lifeline (JLL) have announced an exclusive distribution agreement for the ALPHA1 ablation catheter in the USA, developed by Japan Lifeline for use with the Galaxy Centauri pulsed electric field (PEF) system. Under the terms...
A significant proportion of cardiology trainees are uncomfortable with using telemedicine and feel that better preparation for new-tech medicine is needed, findings of a survey published in the Canadian Journal of Cardiology indicate. The use of telemedicine has become routine...
Abbott has announced a new trial focused on improving the treatment for people simultaneously battling both atrial fibrillation (AF) and heart failure. The TAP-CHF trial (Evaluating the Treatment of Atrial Fibrillation in Preserved Cardiac Function Heart Failure) aims to discover...
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 EFFORTLESS study—the results of which were presented in a late-breaking presentation at the 2021 European...
AtriCure has announced US Food and Drug Administration (FDA) approval of the EPi-Sense system to treat patients diagnosed with long-standing persistent atrial fibrillation (AF). The CONVERGE trial demonstrated superiority in the hybrid AF therapy arm compared to endocardial catheter ablation...
Patients hospitalised with COVID-19 may be at risk of developing heart failure even if they do not have a previous history of heart disease or cardiovascular risk factors, a study published in the Journal of the American College of...
Further efforts should be made to increase participation in atrial fibrillation (AF) screening—particularly in elderly populations, where systematic screening for AF can help to lower the risk of adverse events and reduce comorbidities. This is according to a late-breaking...
Patients receiving an implantable cardioverter defibrillator (ICD) should be regularly screened for anxiety and depression, according to research presented at the European Heart Rhythm Association annual meeting (EHRA 2021, 23–25 April, online). Study author Susanne Pedersen of Odense University Hospital,...
A smartphone-based electrocardiogram (ECG) screening accurately detected previously unknown atrial fibrillation (AF) in American Indians, and more than half who were diagnosed were younger than the recommended screening age of 65, according to new research published in the Journal...
Atrial fibrillation (AF) could be detected during annual foot assessments in patients with diabetes, according to research presented today at the European Heart Rhythm Association annual meeting (EHRA 2021, 23–25 April, online). The finding was presented by Ilias Kanellos of...
This article was sponsored by Biosense Webster Putting the patient at the centre of the discussion is vital to setting the right strategy for the treatment of atrial fibrillation (AF). This is according to Biosense Webster’s recently published report: Atrial...
A project at Oxford University Hospitals NHS Foundation Trust (Oxford, UK) to test how effective smart devices are at detecting heart rhythm problems has received a grant of almost £150,000 from national charity Heart Research UK. Atrial fibrillation (AF) is...
Acutus Medical has announced US Food and Drug Administration (FDA) clearance of the AcQCross family of universal transseptal crossing devices. The transseptal puncture system is specifically engineered to pair with Acutus’ own suite of sheaths and with sheaths sold...
Cardialen has announced the publication of a first-in-human study in the Journal of the American College of Cardiology: Clinical Electrophysiology investigating its low-voltage MultiPulse therapy to terminate atrial fibrillation (AF). The study consisted of 42 patients who were indicated...
The charity Arrhythmia Alliance has launched the Arrhythmia Alliance Healthcare Pioneers Report—Showcasing Best Practice in SVT to provide examples of good care to improve outcomes and quality of life of people with supraventricular tachycardia (SVT). SVT is a rapid increase...
More patients, particularly those with medical risk factors or from underserved communities, opted into telehealth appointments for their cardiovascular care during the COVID-19 pandemic, a cross-sectional study of more than 176,000 ambulatory cardiology visits in Los Angeles County, USA,...
AF Association has launched an opportunistic screening programme to DETECT atrial fibrillation (AF) at COVID-19 vaccination clinics across the UK. The charity has created an online resource hub for healthcare professionals working at vaccine clinics to use to detect...
The American College of Cardiology (ACC) has launched the EP Device Implant Registry, which will include data on ICD and CRT-D procedures previously captured in the NCDR ICD Registry as well as provide the flexibility to capture novel pacemaker...
Acutus Medical has announced initial US enrolment in the company’s AcQForce Flutter Investigational Device Exemption (IDE) clinical trial. The trial is expected to enrol up to 150 subjects in centres globally and will evaluate the safety and efficacy of...
Dipti Itchhaporia has today begun her term as president of the American College of Cardiology (ACC). During her one-year presidency, she will lead the over 54,000-member global organization in its mission to transform cardiovascular care and improve heart health. Itchhaporia...
Patients with valvular atrial fibrillation (AF) who were new users of direct oral anticoagulants (DOACs) were at lower risk for ischaemic stroke or systemic embolism and major bleeding than new users of warfarin, an analysis published in the Annals...
More than a third of female cardiologists polled in a UK survey on discrimination and sexism in the profession have reported receiving unwanted sexual comments, attention or advances from a colleague. The findings of the survey were published online...
Tempus has announced that the US Food & Drug Administration (FDA) has granted the company Breakthrough Device Designation for its ECG analysis platform. The platform, developed in collaboration with Geisinger, aids clinicians in identifying patients at increased risk of...
Daiichi Sankyo has announced that it has entered into a collaborative agreement with three technology partners—FibriCheck, neoHealthTech and Capitol Medicare—to improve timely detection and diagnosis of atrial fibrillation (AF). The partners will be working in collaboration to offer digital solutions...
Bristol Myers Squibb has announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for mavacamten, an investigational, novel, oral, allosteric modulator of cardiac myosin, for patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM)....
Higher procedural volume is associated with better outcomes for percutaneous left atrial appendage occlusion (LAAO) procedures, research published online in JACC: Cardiovascular Interventions has found. Outlining the rationale for the study, lead author Salik Nazir (University of Toledo Medical Center,...
An assessment method known as the index-beat approach could improve the diagnosis of heart failure in patients with atrial fibrillation (AF), authors of a study published online in BMJ: Heart have found. Karina Bunting (Institute of Cardiovascular Sciences, University of...
Medtronic has announced CE mark approval for the SelectSite C304-HIS deflectable catheter system, as well as CE mark labelling expansion for the SelectSecure MRI SureScan Model 3830 cardiac pacing lead for use in His-bundle pacing procedures. Permanent His-bundle pacing is...

Looking ahead to AFIB2021

Far from being the first event in the electrophysiology calendar now to make the switch to a digital-only format, the 2021 edition of the Atrial Fibrillation Symposium (AFIB2021, 18 March, virtual) will be the latest to make its digital...
Qardio has announced that the US Food and Drug Administration (FDA) has granted the company 510(k) clearance for its QardioCore ambulatory ECG device. QardioCore will initially be marketed for holter monitoring applications, for use with QardioMD, Qardio's cloud-based remote...
Five-year follow-up results from the Gore REDUCE study, assessing the Gore Cardioform or Helex septal occluder versus antiplatelet therapy in long-term recurrent stroke prevention, have been published in the March 2021 issue of The New England Journal of Medicine (NEJM). The results...
The American College of Cardiology (ACC) has announced a number of the late-breaking clinical trials to be presented at its 70th annual scientific session (ACC.21, 15–17 May, virtual). The event has recently been switched to an all-virtual format having originally...
CorSystem has announced the first use of its Bipolar Ablation Adapter since the device received CE mark in July 2020. The patient who underwent treatment was suffering from a VT storm which required frequent interventions of implantable cardioverter-defibrillator. The patient...
Inflammatory heart disease is a rare finding among professional athletes with mild or asymptomatic COVID-19 infection, a large-scale study has found. The study, led by Columbia University Vagelos College of Physicians and Surgeons (New York, USA) in collaboration with...
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 tablet, and image processing algorithms to reduce radiation exposure during fluoroscopically guided procedures. The technology is...
Medtronic has announced the first procedures in the investigational device exemption (IDE) pivotal trial to evaluate the PulseSelect pulsed field ablation (PFA) system, a novel, breakthrough technology that uses pulsed electric fields to treat atrial fibrillation (AF). The first procedure...
Atrial fibrillation (AF) burden at six months after catheter ablation is predictive of all-cause mortality and heart failure hospitalisation,  in AF patients with heart failure and low ejection fraction, according to the findings of a subanalysis of the CASTLE-AF...
A global collaboration between international heart failure bodies seeks to standardise the language and practices around the definition and classification of heart failure around the globe. The Heart Failure Society of America (HFSA), the Heart Failure Association of the European...
An open-source platform, OpenEP, has been made available to advance research on atrial fibrillation (AF), which developers claim can perform 90% of the analyses performed in contemporary electrophysiology studies. The platform, which is detailed in a study recently published...
FARAPULSE has announced that the first patients have been treated in the ADVENT trial, a US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial to evaluate the safety and effectiveness of its pulsed field ablation (PFA)...
iRhythm Technologies has announced the results of the SCREEN-AF study, led by researchers at Sunnybrook Health Sciences Centre in Toronto, Canada and University Hospital in Leipzig, Germany, published in JAMA Cardiology. The transatlantic clinical trial found that the use of...
Medtronic has announced new results from the REVERSE trial, evaluating outcomes of cardiac resynchronisation therapy (CRT) for patients with mild heart failure (HF). The analysis of the REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) clinical trial shows...
CardioFocus has announced that results from the HeartLight X3 Pivotal Study have been published online in the journal Circulation: Arrhythmia and Electrophysiology (CircEP), showing that all endpoints of the pivotal study were achieved. The results demonstrated significantly faster pulmonary vein...
Piccolo Medical has announced that it has received US Food and Drug Administration (FDA) clearance of its SmartPICC system. The SmartPICC system offers the ability to navigate peripherally inserted central catheters (PICCs) to the entryway of the heart without the...
The American College of Cardiology (ACC) has announced that its 70th annual scientific session, will be held as an all virtual meeting. The meeting had been due to be held as a hybrid event, across 15–17 May, with in-person...
Urgent action is needed to address the growing burden of heart failure and the impact of COVID-19 in the UK, according to a report issued this week by the Alliance for Heart Failure. The report—‘Heart Failure: A call to action’—makes...
RhythMedix has announced the release of its next-generation RhythmStar wearable device with built-in 4G cellular connectivity. The novel cardiac telemetry monitor is worn for extended remote monitoring without the need for an additional phone or communication device. The technology enables...
MicroPort CRM has launched an online education website—MicroPort Academy CRM—dedicated to cardiac pacing therapy and the functionality of MicroPort CRM products. MicroPort Academy CRM provides personalised and interactive training plans, ranging from diagnosis of ECG tracings to techniques of pacemaker...
The number of patients with heart failure worldwide nearly doubled from 33.5 million in 1990 to 64.3 million in 2017 according to research published in the European Journal of Preventive Cardiology. The analysis used data from the Global Burden of...
Updated recommendations on the optimal antithrombotic treatment of patients with atrial fibrillation (AF) receiving oral anticoagulants after undergoing percutaneous coronary intervention (PCI) have been published this week in the journal Circulation. The recommendations are the latest in a series of...
MedLumics has announced that it has closed an €18 million (US$21.7 million) financing round and has appointed Rich Ferrari as Chairman of the Board of Directors. The company is developing AblaView, an optically-guided real-time ablation catheter system for the treatment...
CardiacSense has received the CE mark to market and sell a medical grade watch which can detect and remotely monitor atrial fibrillation (AF) and heart rate variability (HRV). The indications certified include detection of AF and monitoring of HRV...
Royal Philips has announced that it has completed the acquisition of BioTelemetry, a US provider of remote cardiac diagnostics and monitoring. The acquisition of BioTelemetry is a strong fit with Philips’ cardiac care portfolio, and its strategy to transform the...
A study published in the European Journal of Preventive Cardiology provides “strong evidence” of a causal relationship between elevated blood pressure and atrial fibrillation (AF). Authors of the study suggest that strict blood pressure control measures could be an...
B-Secur has announced that it has received US Food and Drug Administration (FDA) 510(K) clearance for its HeartKey software library. B-Secur’s HeartKey is a suite of EKG/ECG algorithms that combine user identification, health and wellness to generate accurate data encrypted...
The merits of catheter ablation as a first-line treatment for atrial fibrillation (AF) were considered during the second day of AF Symposium 2021 (29–31 January, virtual), which brought together key data from recent clinical trials assessing ablative approaches to...
Hybrid ablation, a procedure which involves “attacking” the atrial substrate from the epicardium and endocardium, has been shown to result in significantly higher freedom from arrhythmia compared to conventional catheter ablation, in persistent and long-standing persistent atrial fibrillation (AF)—late-breaking...
Findings of two studies investigating the use of a lattice-tip catheter for the treatment of atrial fibrillation (AF) were presented during a late-breaking trial session at AF Symposium (29–31 January, virtual) by Vivek Reddy (Icahn School of Medicine at...
Researchers using artificial intelligence (AI) have determined that a smartphone-enabled mobile EKG device can accurately determine a patient’s QT. This can be used to identify patients at risk of sudden cardiac death from congenital long QT syndrome (LQTS) or...
Results of a sub-analysis of the CONVERGE clinical trial, presented during a late-breaking trial session at the digital AF Symposium (29–31 January, virtual), suggest that the hybrid Convergent procedure yields superior outcomes to catheter ablation in patients with long-standing...
Medtronic has received US Food and Drug Administration (FDA) approval for the DiamondTemp ablation (DTA) system which treats patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and who have been unresponsive to drug therapy. The DiamondTemp system is the...
Galaxy Medical, a developer of pulsed electric field (PEF) technology for the treatment of cardiac arrhythmias, has announced that the proprietary Centauri system will be featured in a recorded case presentation during the AF Symposium (29–31 January, virtual). Ante Anić,...
CathVision ApS has announced that its novel cardiac electrophysiology system and artificial intelligence platform to guide ablation therapy for heart rhythm disorders, will be featured at the 26th annual international AF Symposium (29–31 January, virtual). Josef Kautzner, Institute of Cardiology...
Acutus Medical has announced a number presentations relating to its mapping and ablation procedures during 26th Annual International AF Symposium (29–31 January, virtual). The studies demonstrate the beneficial capabilities of guided ablation therapy utilising the company’s entire diagnostic and...
Farapulse announced that it has received the CE mark for its pulsed field ablation (PFA) system for the treatment of paroxysmal atrial fibrillation (AF). The approval will allow the company to commercialise the cardiac PFA system and permits marketing...
RHYTHM AI has announced publication of a clinical outcome study for its STAR (Stochastic Trajectory Analysis of Ranked signals) Mapping system, which is designed to improve outcomes in patients receiving ablation treatment for persistent atrial fibrillation (AF). The article...
Cardialen has been awarded a US$2.8 million National Institutes of Health (NIH) phase II SBIR grant to further the clinical study of low-energy cardioversion of atrial fibrillation (AF) in human subjects in the USA. The grant was awarded after a...
Kardium has raised US$115 million in a new financing round, which will be used to accelerate commercial growth of the Globe mapping and ablation system for the treatment of atrial fibrillation (AF) across Europe and to conduct a clinical...
Following the announcement of CE mark approval for the Aktiia cuffless blood pressure monitor bracelet, Gregoire Wuerzner (Lausanne University Hospital and University of Lausanne, Switzerland) clinical advisor to Aktiia and President of the Swiss Society of Hypertension, discusses the...
The wealthiest countries in Europe have higher death rates from atrial fibrillation (AF) than the least wealthy and these death rates are increasing more rapidly than incidence rates, according to an analysis published in the European Heart Journal. The...
Aktiia has announced that its automated blood pressure monitoring system has received the CE mark as a Class IIa medical device. With the CE Mark, Aktiia now has access to over 40 countries worldwide. Aktiia says that the device is...
InCarda Therapeutics has announced dosing of the first US patient in the company’s multinational INSTANT Phase 2 clinical trial of InRhythm (flecainide for inhalation) in patients with recent-onset paroxysmal atrial fibrillation (PAF). The trial is currently being conducted at...
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 solutions and services, ranging from ambulatory cardiac monitors—including short and long-term Holter monitors—to cardiac event...
Robert Klempfner, is director of the Israeli Center for Cardiovascular Research, and director of the Cardiovascular Prevention and the Cardiac Rehabilitation Institutes at Sheba Medical Center, Raman Gat, Israel. In this article he discusses the uses of remote technology...
Patient engagement is key to optimising outcomes in the treatment of atrial fibrillation (AF) argues Elana Arbelo (Consultant Cardiac Electrophysiologist and Community Cardiologist, Hospital Clinic Barcelona, Spain). In this article she discusses how to activate patient engagement through innovation...
Consumer wearables offer a great potential for the screening of atrial fibrillation (AF), however two thirds of healthcare professionals admit to concerns over mass consumer-initiated testing for AF. These are the findings of a survey published in the European Journal...
“I believe, if you zoom out into the future, and you look back, and you ask the question, ‘What was Apple’s greatest contribution to mankind?’ it will be about health.” This was the vision set out by Tim Cook,...
A study of nearly 108,000 people has found that people who regularly drink a modest amount of alcohol are at increased risk of atrial fibrillation (AF). The study, published in the European Heart Journal, found that, compared to drinking...
Volta Medical, a French health technology startup working on artificial intelligence (AI) algorithms to treat cardiac arrythmias, has announced that it has successfully raised €23 million in financing round led by Gilde Healthcare with participation of existing shareholder Pasteur...
The American College of Cardiology (ACC) is partnering with BioIntelliSense, a continuous health monitoring and clinical intelligence company, to advance remote patient monitoring (RPM) programmes for cardiac care. The partnership will see BioIntelliSense provide the use of its BioButton...
A letter published in the journal Heart Rhythm has warned of possible interference to implantable cardioverter defibrillator (ICD) therapy caused by magnets in the iPhone 12. The letter, authored by Joshua Greenberg and colleagues from the Henry Ford Heart and...
Jian’an Wang (Heart Center, Zhejiang University, Hangzhou, China) has been named the inaugural editor-of-chief of JACC: Asia, a new journal from the American College of Cardiology. The journal will publish original manuscripts and clinical practice guidelines specific to Asian...
Results of a prospective randomised evaluation of using high power during CLOSE-guided pulmonary vein isolation (PVI) using the Thermocool Smarttouch (Biosense Webster) device—the POWER-AF study—have been published online in Circulation: Arrhythmia and Electrophysiology. Authors Jean-Yves Wielandts (Department of Cardiology, AZ...
Medtronic Canada has received a Health Canada licence for Micra  AV, the world's smallest pacemaker with atrioventricular (AV) synchrony. Micra AV is indicated for the treatment of patients with AV block, a condition in which the electrical connection between...
Elimination of distal coronary sinus (CS) to left atrial (LA) connections reduced atrial arrhythmia recurrences compared to standard pulmonary vein (PV) isolation and non-PV trigger ablation in patients undergoing a first atrial fibrillation (AF) ablation procedure findings of a...
The American College of Cardiology (ACC) has issued guidance recommending against triple antithrombotic therapy in patients with atrial fibrillation (AF), due to its increased risk of bleeding. The 2020 Expert Consensus Decision Pathway (ECDP), published today, aims to fill the...
Royal Philips has agreed a merger agreement with BioTelemetry, a cardiac monitoring company focused on the diagnosis and monitoring of heart rhythm disorders. Philips will commence a tender offer to acquire all of the issued and outstanding shares of BioTelemetry...
Abbott has announced that the US Food and Drug Administration (FDA) has approved updated labelling for the company's HeartMate 3 heart pump to be used in paediatric patients with advanced refractory left ventricular heart failure. With the updated labelling,...
Biotronik has today announced US Food and Drug Administration (FDA) clearance and availability of the Vital Data Sensor, which identifies body temperature increases potentially associated with fever, in the new Biomonitor IIIm injectable cardiac monitor (ICM), as shown in...
CardioFocus has announced that more than 10,000 patients worldwide have been treated with the HeartLight endoscopic ablation system. The HeartLight system is a catheter ablation technology for controlled and consistent pulmonary vein isolation (PVI), the gold standard treatment for atrial...
MicroPort Cardio Rhythm Management (CRM) has announced the first enrolment in the Astral-4LV clinical trial to evaluate the safety and efficiency of Axone, a breakthrough quadripolar left ventricular lead. Axone is designed for use in heart failure patients with...
Acutus Medical has announced CE mark approval and the European launch of its integrated family of transseptal crossing products, designed to deliver safe and efficient access to the left atrium. Coupled with their previously received FDA clearance, Acutus now...
Volta Medical has announced that it has obtained US Food and Drug Administration (FDA) clearance for its VX1 AI (artificial intelligence) software. According to Volta, this is the first FDA clearance for an AI based tool in interventional cardiac...
Biotronik has announced CE mark approval for the AlCath Force the gold-tipped force sensing ablation catheter system. The AlCath Force was designed specifically to show physicians—in real-time—how much contact is being applied to the heart wall during ablation procedures, helping...
Fourteen drinks a week is linked with a higher risk of stroke and embolism in patients with atrial fibrillation (AF), according to research published in EP Europace. “Our study suggests that atrial fibrillation patients should avoid heavy alcohol consumption to prevent...
Itamar Medical has announced the publication of a study in the December 2020 edition of Nature and Science of Sleep validating the use of its WatchPAT device against the gold standard in-lab polysomnogram (PSG) in the diagnosis of sleep...
Acutus Medical has announced the launch of the AcQBlate force sensing ablation system in Europe after securing CE mark for the company’s AcQBlate FORCE ablation catheter and the Qubic force sensing module (Qubic Force). The AcQBlate force sensing ablation system,...
Cathy Gates has been named as the new CEO of the American College of Cardiology (ACC), effective immediately. Gates has been serving as interim CEO of the ACC since April. “We are excited to have Cathy take the helm of...
The use of direct oral anticoagulants (DOACs) did not reduce the rate of hospitalisation, intensive care admission or fatality due to COVID-19, according to the results of a Swedish observational study, published in The Journal of Internal Medicine. DOACs are...
iRhythm Technologies has announced it is the first technology to pass through a new digital health tech pilot, resulting in a successful recommendation for adoption from the National Institute for Health and Care Excellence (NICE). iRhythm’s Zio XT Service—an ambulatory...
Rhythm AI has announced publication of a human clinical outcome study for its Stochastic Trajectory Analysis of Ranked signals (STAR) mapping system in Circulation: Arrhythmia and Electrophysiology. STAR mapping is designed to improve outcomes in patients receiving ablation treatment...
Three-year clinical outcomes of the mHealth Screening to Prevent Strokes—mSToPS—study evaluating silent, or previously undiagnosed, atrial fibrillation (AF) in moderate-risk individuals using Zio, the wearable ECG patch (iRhythm Technologies), were presented at the American Heart Association 2020 scientific sessions...
Atrial fibrillation (AF) was detected up to 10 times more frequently in high risk patients recovering from heart surgery who wore a continuous cardiac monitor for a month, compared to patients who had usual follow-up care following their procedure,...
Medtronic has announced the presentation of results of three studies which it says demonstrate that cryoablation is superior to drug therapy for first-line treatment for the prevention of paroxysmal atrial fibrillation (PAF). Two studies—Cryo-FIRST trial and the investigator-initiated EARLY...
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 trial of InRhythm (flecainide for inhalation) in patients with recent-onset paroxysmal atrial fibrillation (PAF). Data...
The primary results from the RIVER Trial—Rivaroxaban for Valvular Heart disease and Atrial Fibrillation—show that rivaroxaban is comparable to warfarin for patients with bioprosthetic mitral valves. The findings were presented during a late-breaking trial session at the American Heart...
Adagio, developer of the intelligent Continuous Lesion Ablation System (iCLAS), has announced that it has closed a US$42.5 million Series E equity financing. Proceeds from the financing will be used to support the ongoing iCLAS Investigational Device Exemption (IDE)...
Kardium has announced the first clinical use of the Globe Positioning System—a 3D mapping and navigation feature of its flagship product, the Globe Mapping and Ablation System. The Globe System is designed for the treatment of atrial fibrillation (AF)—involving...
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 were completed with the research organisation IMMR and pave the way for the first-in-human trial...
AliveCor has announced the appointment of Toby Cosgrove to its board of directors. For more than 13 years, through to 2017, Cosgrove served as president and chief executive officer of Cleveland Clinic where he was responsible for overseeing the...
HeartHero has announced that its automated external defibrillator (AED) device—known as Elliot—has received CE mark approval. In a press release, the company said that its goal for the device to become the lowest-cost, easiest-to-use, and most portable AED on...
Structural racism is a major cause of poor health and premature death from heart disease and stroke, according to a presidential advisory issued today by the American Heart Association (AHA). “Call to Action: Structural Racism as a Fundamental Driver...
Higher fitness levels reduced the risk of developing atrial fibrillation (AF) by 30‒50% in a study of male, African American veterans, according to preliminary research to be presented at the American Heart Association's Scientific Sessions 2020 (13–17 November, virtual). “Engaging...
Payments from device manufacturers to physicians are likely to have a bearing on device selection in patients receiving an implantable cardioverter defibrillator (ICD) or cardiac resynchronisation therapy-defibrillator (CRT-D), a study published in the Journal of the American Medical Association...
Rates of procedural success and complications were no different between de novo cardiac resynchronisation therapy (CRT) implantations and upgrades, a study published in JACC: Clinical Electrophysiology has concluded. The study compared rates of procedural success and complications between de...
Abbott has announced has announced the receipt of CE mark and approval in Australia for its EnSite X EP System, and is launching the system throughout Europe and Australia. Abbott sought physician feedback to develop the EnSite X System to...
Researchers have designed a new machine learning-based approach for detecting atrial fibrillation (AF) drivers, small patches of the heart muscle that are hypothesised to cause this most common type of cardiac arrhythmia. This approach may lead to more efficient...
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 within a broad population of patients with non-valvular atrial fibrillation (NVAF), including those who are...
The European Society of Cardiology (ESC) has announced that its full portfolio of congresses, teaching courses and exams in 2021—including the ESC Congress 2021—will be held online, due to the continuing COVID-19 pandemic. A statement issued on behalf of the...
InCarda Therapeutics, has raised US$30 million through the first close of a Series C equity financing. The financing was led by an affiliate of Innoviva and included existing investors Deerfield Management, HealthCap and Morningside Venture. Proceeds from the financing...
Magnetic resonance imaging (MRI) examinations can be performed safely in patients with non-MR compatible cardiac devices, including those who are pacemaker-dependent or have abandoned leads, according to a study published in Radiology: Cardiothoracic Imaging. Many patients rely on implanted cardiac...
A research programme into understanding the underlying causes of unexplained cardiac arrest has received significant backing from the British Heart Foundation (BHF). The four-year project, which is a collaboration between researchers from the UK, Germany and the Netherlands, will study...
The Journal of the American College of Cardiology (JACC) has issued a three-part focus seminar on COVID-19 in 2020 to address the complex relationship between COVID-19 and the heart. The series includes a paper discussing a new COVID-19-related cardiometabolic syndrome...
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 closure (LAAC) technology.  Data were presented at TCT Connect 2020 (14 – 18 October, virtual)...
One in five high-risk patients undergoing major non-cardiac surgery will develop one or more heart complications within a year, according to research published today in European Heart Journal – Acute Cardiovascular Care, a journal of the European Society of...
Coala Life has announced the results of a late breaking trial on cryptogenic stroke patients. In the TEASE-study, recently published in the British Medical Journal, the Coala Heart Monitor was used to evaluate 100 patients after cryptogenic stroke. Patients...
Galaxy Medical, a developer of pulsed electric field (PEF) technology, has announced that the first patients in the ECLIPSE-AF study were successfully treated with the proprietary Centauri system by Ante Anić in Split, Croatia. The multicentre trial is designed...
VivaLNK and AMPS have partnered to advance remote patient monitoring (RPM) for clinical trials, combining AMPS’ continuous electrocardiogram (ECG) recording suite with VivaLNK medical wearable sensors to provide real-time and retrospective analysis for continuous ECG datasets in remote environments. VivaLNK...
Rhythm AI has today announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with its multicentre ‘ROCSTAR’ clinical trial. This programme will assess the company’s STAR Mapping System as a...
Patients with postoperative atrial fibrillation (AF) after coronary artery bypass graft (CABG) surgery are at a higher risk of cerebrovascular accidents (CVAs) up to 10 years after the procedure, a study published in Circulation has found. The authors of...
People with atrial fibrillation (AF) have a reduced risk of dementia if they undergo catheter ablation to restore the normal rhythm of their heart, according to a new study published in the European Heart Journal. Previous work, published last year...
Johnson & Johnson Medical Devices Companies has announced the US Food and Drug Administration (FDA) approval of Biosense Webster’s Thermocool Smarttouch SF ablation catheter for the treatment of persistent atrial fibrillation (AF). The approval is based on results of a...
AngelMed has announced the first implant of the next-generation AngelMed Guardian system as part of the ALERTS-Continued Access Study. The AngelMed Guardian is an implantable, patient alerting system designed to warn patients to seek medical attention for acute coronary...
SentiAR has received US Food and Drug Administration (FDA) 510(k) clearance for its CommandEP system, the first holographic guidance system to be used during an invasive cardiac procedure. The CommandEP system allows electrophysiologists to visualise 3D electroanatomic models in...
Johnson & Johnson has announced that Biosense Webster has enrolled and treated the first patients in its inspIRE clinical study in Europe. The study will evaluate the safety and effectiveness of the Varipulse catheter and Trupulse generator, investigational technologies...
Shouvik Haldar (London, UK) has been announced as the new A-A Heart Rhythm Congress programme director, following the decision by Kim Rajappan (Oxford, UK) to step down following a four-year tenure. The new appointment was announced by Trudie Lobban, founder...
Research has identified 2,085 excess deaths in England and Wales linked to cardiovascular disease during the peak of the COVID-19 pandemic. On average, that is 17 deaths each day over four months from 2 March to 30 June 2020....