Boston Scientific has secured approval from the US Food and Drug Administration (FDA) to broaden the instructions for use of its Farapulse Pulsed Field Ablation (PFA) System.
The revised labelling now permits the use of the system in treating drug-refractory, symptomatic persistent atrial fibrillation (AF), a condition characterised by an irregular heart rhythm lasting at least seven days.
According to Boston Scientific, atrial fibrillation is estimated to affect approximately 59 million individuals globally. Many of them experience the persistent form, which can lead to symptoms such as dizziness, fatigue, and shortness of breath, and may increase the risk of stroke.
The Farapulse PFA System addresses AF by utilising pulsed field energy delivered through a catheter to ablate heart tissue. This recent FDA approval modifies the instructions for both the FARAWAVE PFA Catheter and FARAWAVE NAV PFA Catheter to include patients with persistent AF.
Boston Scientific AF Solutions chief medical officer Brad Sutton said: “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.
“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.”
The FDA’s decision was informed by clinical results from phase one of the ADVANTAGE AF trial presented at the AF Symposium 2025 and published in the Journal of the American College of Cardiology.
The trial, a prospective, single-arm study, involved 260 patients at 43 global sites who were intolerant to at least one Class I/III anti-arrhythmic drug. It reported no cases of stroke or major access complications, and an AF recurrence-free rate of 85.3%.
Physicians conducting three or more procedures observed an improved recurrence-free rate of 91.4%.
Distinctly different from thermal cardiac ablation methods, pulsed field ablation therapy employs brief electrical pulses to selectively target cardiac tissue for irreversible electroporation without inducing thermal damage.
By focusing on cardiomyocytes, which have a lower damage threshold compared to other tissues, PFA minimises collateral injury.
Boston Scientific foresees obtaining CE mark approval and regulatory clearance in Japan and China in the near future. Additionally, the company has commenced the ReMATCH investigational device exemption (IDE) clinical trial across 40 centres in the US and Asia, involving around 375 patients.
This trial will assess the safety and efficacy of the FARAWAVE PFA Catheter for posterior wall ablation and pulmonary vein isolation in patients with recurrent persistent AF after prior ablation therapies. It will also examine the adjunctive use of the FARAPOINT PFA Catheter for cavotricuspid isthmus and left atrial ablations.
