Kardium today announced positive one-year outcomes from the first-in-human trial of its Globe pulsed field ablation (PFA) system. Results came out of the PULSE-EU trial of the company’s Globe system. Vancouver, British Columbia-based Kardium had its findings presented at HRS 2024 earlier this month and published in the Heart Rhythm Journal. Dr. Vivek Reddy of […]
HRS 2024
Volta Medical has positive data for AI-powered AFib treatment
Volta Medical today announced positive results from a study of its AI decision support system for tailoring cardiac ablation procedures. The Marseille, France-based company’s findings from an FDA investigational device exemption (IDE) trial were presented at Heart Rhythm Society 2024. Results showed that Volta’s AI decision support system, in addition to pulmonary vein isolation (PVI), […]
HeartBeam AI with VCG outperforms cardiologists in detecting arrhythmias
HeartBeam (Nasdaq:BEAT) today announced new data highlighting the potential of its AI combined with vectorcardiography (VCG). Study results showed that HeartBeam AI with VCG outperformed an expert panel of heart rhythm cardiologists in detecting atrial flutter. HeartBeam’s AI algorithm uses deep learning to detect abnormalities in the timing or pattern of heartbeats. VCG measures the […]
Boston Scientific Farapulse trial highlights post-ablation arrhythmia burden’s effect on outcomes
Boston Scientific today shared new data looking at the impact of post-ablation atrial arrhythmia (AA) burden outcomes. The ADVENT trial compared Boston Scientific’s Farapulse pulsed field ablation (PFA) system to thermal ablation. In August, the company had positive 12-month results from same trial. Earlier this year, it became the second PFA system approved by the […]
Boston Scientific has positive modular CRM data
Boston Scientific today shared data supporting the use of its modular cardiac rhythm management (mCRM) technology. Marlborough, Massachusetts-based Boston Scientific presented data in an abstract at Heart Rhythm Society in Boston today. The mCRM system features a novel leadless pacemaker (LP) with wireless communication to a subcutaneous implantable cardioverter defibrillator (S-ICD). This combination delivers anti-tachycardia […]
Medtronic data shows safety and efficacy of Affera, Sphere-9 all-in-one ablation
Medtronic today announced data demonstrating the safety and efficacy of its Affera mapping and ablation system with the Sphere-9 catheter. Affera received CE mark more than a year ago. In January, CEO Geoff Martha reported “good progress” in bringing the Affera Sphere-9 PFA mapping and ablation catheter to the U.S. market this year. Medtronic recently […]
Biosense Webster presents data backing Varipulse pulsed field ablation
Johnson & Johnson MedTech’s Biosense Webster today shared positive results from a clinical trial of its Varipulse pulsed field ablation (PFA) platform. The company presented results from its admIRE pivotal clinical trial and additional data from the Virtue study at HRS 2024. Both studies evaluated Varipulse for the treatment of cardiac arrhythmias, including AFib. Biosense Webster’s […]
AliveCor has positive study results for handheld, AI-powered ECG
AliveCor announced new study results backing its handheld ECG technology at Heart Rhythm Society 2024 in Boston. One study evaluated the accuracy of the recordings and interpretations of the Kardia 12L device that records 12-lead ECG. It compared the accuracy of the AI-powered device to standard 12-lead ECG technology. Kardia 12L uses a deep neural […]
Medtronic’s investigational defibrillation lead meets primary study endpoints
Medtronic today announced positive study results for its investigational OmniaSecure catheter-delivered defibrillation lead. The system met its primary safety and effectiveness endpoints and exceeded prespecified performance goals in the LEADR pivotal trial. Medtronic presented results at Heart Rhythm Society’s 2024 meeting in Boston and published results in the journal Heart Rhythm. Implantable cardioverter defibrillators (ICDs) […]
Adagio Medical wins FDA IDE for cryoablation study, completes first commercial cases in Europe
Adagio Medical announced today that it picked up FDA investigational device exemption (IDE) for a study of its VT cryoablation system. The Laguna Hills, California-based company also completed the first commercial procedures in Europe following CE mark approval. Adagio Medical designed its VT system with the vCLAS cryoablation catheter based on its proprietary ultra-low cryoablation […]
CathRx says first-in-human data backs pulsed field ablation tech
CathRx announced today that results from its first-in-human study support its ElectroPulse pulsed field ablation (PFA) system. The Sydney, Australia-based company, which just emerged from stealth mode, designed ElectroPulse to treat symptomatic AFib. The system features the ElectroPulse generator, variable loop mapping and ablation catheter with the ElectroTouch contact sensing module. According to a news […]
