Boston Scientific secures FDA approval for expanded use of FARAPULSE PFA System to treat persistent atrial fibrillation, marking a breakthrough in non-thermal cardiac ablation.
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| Boston Scientific's FARAPULSE PFA System gains FDA approval for treating persistent atrial fibrillation, based on data showing over 85% effectiveness and no major complications. Image: FARAPULSE/ CH |
Marlborough, Massachusetts, USA — July 7, 2025:
Boston Scientific Corporation announced today that it has received U.S. Food and Drug Administration (FDA) approval to expand the use of its FARAPULSE Pulsed Field Ablation (PFA) System for the treatment of drug-refractory, symptomatic persistent atrial fibrillation (AF) — a significant milestone in the evolution of non-thermal cardiac ablation technologies.
Persistent AF, a form of arrhythmia lasting more than seven days, impacts millions globally and can lead to debilitating symptoms and increased risk of stroke. The FARAPULSE system uses pulsed field energy delivered via catheter to precisely ablate heart tissue, restoring normal rhythm with a focus on minimizing damage to surrounding structures.
This regulatory update broadens the instructions for use (IFU) for the FARAWAVE and FARAWAVE NAV PFA catheters, enabling physicians to treat patients with persistent AF — a population that often requires more complex interventions than those with paroxysmal AF.
“Backed by clinical evidence and our global commercial experience, this update advances our efforts to further shape the future of AF treatment with safe and effective ablation technologies,” said Dr. Brad Sutton, Chief Medical Officer, AF Solutions at Boston Scientific.
The approval was based on phase one results from the ADVANTAGE AF clinical trial, involving 260 patients at 43 global sites. The study met both safety and effectiveness endpoints, with a symptomatic AF recurrence-free rate of 85.3%, and a higher rate of 91.4% among experienced operators. Importantly, there were no reported cases of stroke, pulmonary vein stenosis, atrio-esophageal fistula, or other major complications.
Boston Scientific is anticipating regulatory approvals in Europe (CE mark), Japan, and China later this year. Meanwhile, the company has launched the ReMATCH IDE clinical trial, which will study approximately 375 patients across 40 sites in the U.S. and Asia. This trial will evaluate the FARAWAVE system for redo ablations, as well as the use of the FARAPOINT PFA Catheter for complex anatomical targets such as the cavotricuspid isthmus and mitral isthmus.
With this expanded indication, Boston Scientific reinforces its position at the forefront of next-generation AF treatment, offering safer, more targeted alternatives to thermal ablation and expanding access for patients with persistent forms of the condition.