Field Medical announced today that it received FDA breakthrough device designation for its FieldForce pulsed field ablation (PFA) system. The FDA also accepted the technology into its Total Product Lifecycle Advisory Program (TAP). TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates … [Read more...] about FDA grants breakthrough nod to pulsed field ablation tech from Farapulse founder’s Field Medical
Pulsed Field Ablation
First U.S. cases performed with Medtronic Affera ablation system
A hospital in Texas announced today that its electrophysiologists completed the first U.S. cases with the Medtronic (NYSE:MDT) Affera platform. EPs at the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center performed the procedures with Affera. Dr. Andrea Natale and Dr. Amin Al-Ahmad conducted the first procedure on Nov. 7. A … [Read more...] about First U.S. cases performed with Medtronic Affera ablation system
Boston Scientific resumes study of pulse field ablation as first-line AFib therapy
Boston Scientific (NYSE: BSX) is resuming its “Avant Guard” study of pulse field ablation as a first-line therapy for persistent atrial fibrillation (AFib). The device developer paused the trial last month, with CEO Mike Mahoney citing the need to “assess a few unanticipated observations.” Boston Scientific said it did not halt the trial due to … [Read more...] about Boston Scientific resumes study of pulse field ablation as first-line AFib therapy
Johnson & Johnson MedTech wins FDA nod for Varipulse PFA
Johnson & Johnson MedTech announced today that the FDA approved its Varipulse pulsed field ablation (PFA) platform for treating AFib. Varipulse treats AFib with a single device that combines PFA with the Carto 3 mapping system. With approval, Johnson & Johnson joins Medtronic and Boston Scientific as companies with PFA technologies … [Read more...] about Johnson & Johnson MedTech wins FDA nod for Varipulse PFA
Johnson & Johnson completes pilot enrollment in Omnypulse trial
Johnson & Johnson MedTech today announced the completed enrollment of the pilot phase of a clinical trial for its Omnypulse platform. The OMNY-AF clinical trial evaluates the investigational platform for the treatment of symptomatic paroxysmal AFib in the U.S. and Australia. The single-arm, multi-center trial completed the pilot phase … [Read more...] about Johnson & Johnson completes pilot enrollment in Omnypulse trial
Johnson & Johnson reports first commercial Varipulse PFA use in Canada
Johnson & Johnson MedTech [WtwhTicker symbol="JNJ"](NYSE: JNJ)[/WtwhTicker] today announced the first completed commercial case with its Varipulse platform in Canada. The company said in a post on LinkedIn that doctors at the Ottawa Heart Institute completed the first commercial case with Varipulse. Johnson & Johnson said the procedure … [Read more...] about Johnson & Johnson reports first commercial Varipulse PFA use in Canada
Abbott progresses pulsed field ablation studies, launches cardiac mapping tool
Abbott today announced new milstones supporting its suite of pulsed field ablation (PFA) solutions in electrophysiology. The company completed enrollment early for its VOLT-AF FDA investigational device exemption (IDE) study evaluating the Volt PFA system. It also launched its FOCALFLEX trial to assess its TactiFlex duo ablation catheter, … [Read more...] about Abbott progresses pulsed field ablation studies, launches cardiac mapping tool
J&J’s Biosense Webster completes enrollment in pulsed field ablation trial, earns coverage win in Japan
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 … [Read more...] about J&J’s Biosense Webster completes enrollment in pulsed field ablation trial, earns coverage win in Japan
How Medtronic designed the PulseSelect pulsed field ablation system for AFib
Medtronic‘s PulseSelect became the first pulsed field ablation (PFA) system to win FDA approval for treating atrial fibrillation (AFib) in December 2023. The world’s largest medical device manufacturer achieved that milestone about 15 years after one of its engineers, Mark Stewart, coined the term “pulsed field ablation” in a research paper … [Read more...] about How Medtronic designed the PulseSelect pulsed field ablation system for AFib
Farapulse founder’s Field Medical begins first-in-human pulsed field ablation trial
Field Medical announced today that it began the first-in-human study of its FieldForce pulsed field ablation (PFA) system. The company began its study evaluating FieldForce at Na Homolce Hospital in Prague, Czech Republic. It expects the VCAS study to enroll up to 60 patients at up to five sites around the world. Cardiff-by-the-Sea, … [Read more...] about Farapulse founder’s Field Medical begins first-in-human pulsed field ablation trial
