Boston Scientific (NYSE: BSX) announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for its Farapulse™ Pulsed Field Ablation (PFA) system, a key technology in the treatment of atrial fibrillation (AFib).
Originally approved for paroxysmal AFib, the Farapulse system can now also be used to treat drug-refractory, symptomatic persistent AFib, where patients experience abnormal heart rhythms lasting more than seven days. This label expansion applies to both the Farawave™ PFA catheter and the Farawave™ Nav PFA catheter, updating their instructions for use.
The FDA’s decision follows clinical results from the ADVANTAGE AF trial, shared earlier this year, which provided strong evidence supporting the system’s safety and effectiveness in this more complex patient group. Boston Scientific had projected regulatory approval for this indication in the second half of 2025.
The company also anticipates securing CE Mark approval in Europe and regulatory clearance in Japan and China in the coming months for the same expanded indication.
To further evaluate the platform, Boston Scientific has launched the ReMATCH IDE clinical trial, enrolling approximately 375 patients across 40 centers in the U.S. and Asia. The study will assess the use of the Farawave catheter for posterior wall ablation and pulmonary vein isolation in patients with persistent AFib who have experienced a recurrence after previous ablation therapies—including pulsed field, radiofrequency, or cryoablation.
The trial also investigates adjunctive use of the Farapoint™ catheter for cavotricuspid isthmus ablation and mitral isthmus ablation, addressing patients with complex arrhythmias that often require re-do procedures.
“This label expansion marks a major milestone in our mission to offer safer, more effective ablation options for patients with persistent and complex AFib,” said Dr. Brad Sutton, Chief Medical Officer, AFib Solutions at Boston Scientific. “We’re excited to continue building evidence through upcoming clinical trials that reflect real-world patient needs.”
The Farapulse system represents a non-thermal, tissue-selective approach to cardiac ablation, and is increasingly being seen as a next-generation alternative to traditional thermal methods.