Boston Scientific announces data supporting use of FARAPULSE PFA system

The company states: “Boston Scientific (BSX) announced data supporting the use of the FARAPULSE Pulsed Field Ablation System* and the WATCHMAN FLX Left Atrial Appendage Closure Device, respectively, during a late-breaking science session at AF Symposium 2025. Currently, the FARAPULSE PFA System is approved for pulmonary vein isolation- PVI – in patients who have paroxysmal AF, an irregular heartbeat that occurs occasionally and typically spontaneously resolves back to normal rhythm. The ADVANTAGE AF study examined use of the FARAPULSE PFA System for both PVI and posterior wall ablation in patients who have persistent AF, where individuals experience an irregular or rapid heartbeat that lasts longer than seven days and which represent 25% of all AF cases.1 The prospective, single arm trial included 260 patients enrolled at 43 global sites who were drug intolerant to at least one Class I/III anti-arrhythmic drug. The late-breaking session also included a prespecified sub-analysis from the OPTION clinical trial that built upon the positive primary endpoint results presented at the American Heart Association 2024 meeting and published in The New England Journal of Medicine. In line with the overall 36-month outcomes from this first head-to-head study of the WATCHMAN FLX device and direct oral anticoagulants, he sub-analysis of 1,600 patients with atrial fibrillation who underwent a device implantation either concomitantly or sequentially demonstrated that consistent with the previously presented primary safety and efficacy endpoint data presented in November 2024, concomitant LAAC with the WATCHMAN FLX device following an ablation demonstrated a statistically significant 44% reduction in non-procedural bleeding outcomes compared to OAC at 36 months and similar efficacy outcomes, with the primary efficacy endpoint defined as all-cause death, stroke or systemic embolism.”