US major Boston Scientific Corporation (NYSE: BSX) has announced the presentation of positive results from the ADVANTAGE AF study for its FARAPULSE Pulsed Field Ablation (PFA) System and the OPTION study for its WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device at the AF Symposium 2025. These studies highlight the company’s ongoing commitment to advancing treatments for atrial fibrillation (AF) and stroke prevention.
ADVANTAGE AF Study: FARAPULSE PFA System
The ADVANTAGE AF study examined the use of the FARAPULSE PFA System, which is approved for pulmonary vein isolation (PVI) in patients with paroxysmal AF. The study expanded the application to include both PVI and posterior wall ablation (PWA) in patients with persistent AF. The study enrolled 260 patients at 43 global sites who were intolerant to at least one Class I/III anti-arrhythmic drug (AAD). At month 12, the study reached its safety and efficacy endpoints, with 63.5% of patients free from AF, atrial flutter, atrial tachycardia, re-ablation, cardioversion, and use of a new or escalated dose of Class I/III AAD or amiodarone. The symptomatic AF recurrence-free rate was 85.3%.
OPTION Study: WATCHMAN FLX LAAC Device
The OPTION study assessed the WATCHMAN FLX device versus direct oral anticoagulants (95% DOAC, 5% warfarin) in a head-to-head comparison. The data showed that, compared to oral anticoagulants, both concomitant and sequential left atrial appendage closure (LAAC) with the WATCHMAN FLX device significantly reduced non-surgical bleeding events at 36 months (concomitant: 8.0% vs. 13.3%, sequential: 8.8% vs. 21.5%). The effectiveness results were similar (concomitant: 7.0% vs. 6.7%, sequential: 4.2% vs. 5.3%). Whether used concomitantly (stroke incidence rate: 2.3% vs. 2.5%) or sequentially (stroke incidence rate: 1.1% vs. 1.6%), the WATCHMAN FLX device showed similar performance in stroke protection compared to oral anticoagulants.
Strategic Implications
The positive results from the ADVANTAGE AF and OPTION studies underscore Boston Scientific’s leadership in developing innovative solutions for AF and stroke prevention. The FARAPULSE PFA System and WATCHMAN FLX LAAC Device offer new treatment options for patients, potentially improving outcomes and reducing the need for long-term anticoagulation therapy. These advancements are expected to enhance Boston Scientific’s position in the cardiovascular market and contribute to better patient care.-Fineline Info & Tech
