Johnson & Johnson MedTech’s Biosense Webster announced today that it completed enrollment in its Omny-IRE pulsed field ablation (PFA) trial. The prospective, multi-center, non-randomized trial enrolled 188 patients in Europe and Canada. It evaluates the safety and effectiveness of the company’s Omnypulse platform. The J&J unit designed it for mapping and treating symptomatic paroxysmal AFib during […]
Pulsed-Field Ablation (PFA)
Pulse Biosciences touts first-in-human pulsed field ablation cases
Pulse Biosciences (Nasdaq:PLSE) today announced the first completed cases in a first-in-human feasibility study of its pulsed field ablation system. Hayward, Calif.–based Pulse Biosciences’ study evaluates its novel Cardiac Surgery System for ablating cardiac tissue to treat AFib. The Cardiac Surgery System received FDA breakthrough device designation last month. The technology utilizes Pulse Biosciences’ CellFX […]
Adagio Medical goes public in SPAC merger
Adagio Medical announced that it completed its previously announced business combination with Arya Sciences Acquisition Corp IV. Arya, a special purpose acquisition company (SPAC), agreed to acquire Adagio in February. The acquisition takes Adagio public, trading under the “ADGM” ticker on the Nasdaq market as of yesterday, Aug. 1. Adagio continues operations under its current […]
Volta Medical, GE HealthCare partner on AI-driven electrophysiology tech
Volta Medical announced today that it entered into a joint development agreement with GE HealthCare . The development deal aims to integrate Volta Medical’s latest AI solution, the AF-Xplorer, with GE Healthcare’s Prucka 3 and CardioLab EP recording system. This combination could enhance performance and streamline workflows for electrophysiologists during ablation procedures for AFib. Volta […]
Boston Scientific wins Farapluse approval in China
Boston Scientific (NYSE: BSX) has gained access to another huge market for its Farapulse pulsed field ablation system for treating atrial fibrillation. “I’m thrilled to share that the novel Farapulse pulsed field ablation system has received approval in China! With 12 million people in China living with atrial fibrillation (AF), this approval marks our commitment […]
Pulse Biosciences wins FDA breakthrough nod for AFib-treating pulsed field ablation tech
Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted breakthrough device designation for its pulsed field ablation system. Shares of PLSE rose more than 20% in mid-morning trading on the back of this announcement. Hayward, California–based Pulse Biosciences’ technology utilizes its CellFX nanosecond pulsed field ablation (nsPFA) technology and percutaneous electrode system, which the FDA […]
Kardium raises $104M for pulsed field ablation system
Kardium today announced that it raised $104 million in a new financing round to support its Globe pulsed field ablation (PFA) system. Existing investor Fidelity Management & Research Company led the round. Funds and accounts advised by T. Rowe Price added follow-on participation and new investor Durable Capital Partners joined as well. The new financing […]
Kardium has positive pulsed field ablation data
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 […]
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), […]
The top stories out of Heart Rhythm Society 2024
Once again, the top players in cardiac care gathered en masse as Heart Rhythm Society (HRS) 2024 took place in Boston last week. From implantable rhythm management devices to AI-powered monitoring and diagnostic technology, Heart Rhythm 2024 had it all. Once again, pulsed field ablation (PFA) took center stage as companies continue to build on […]
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 […]
