FDA expands approval of Boston Scientific’s Farapulse PFA system
Boston Scientific has received an expanded approval from the U.S. Food and Drug Administration (FDA) for its Farapulse Pulsed Field Ablation (PFA) System. More U.S. heart patients are now eligible to be treated with the technology than ever before.
The Farapulse PFA system first gained FDA approval to treat patients with symptomatic, paroxysmal atrial fibrillation (AFib) back in January 2024. This new approval covers patients with symptomatic, persistent AFib that is resistant to drug treatment.
“Backed by clinical evidence and our global commercial experience, this update advances our efforts to further shape the future of AFib treatment with safe and effective ablation technologies,” Brad Sutton, MD, chief medical officer of AFib solutions for Boston Scientific, said in a statement. “We look forward to studying the system in new clinical trials, including patients in need of re-do ablations and those with more complex arrhythmias, which account for a large portion of the procedures today still using thermal ablation.”
This update covers both the Farawave and Farawave NAV PFA catheters. According to Boston Scientific, the company also hopes to gain CE mark approval and regulatory approvals in China and Japan in the months ahead.
Additional PFA research underway
Boston Scientific also announced the launch of its ReMATCH IDE clinical trial, which will track the safety and effectiveness of using the Farawave PFA catheter for posterior wall ablation and pulmonary vein isolation in patients with persistent AFib. The study is expected to enroll approximately 375 patients in the United States and Asia who have already undergone a prior ablation procedure.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.