Boston Scientific Corp. reported positive data for two key atrial fibrillation therapies at AF Symposium 2025 on January 17. In late-breaking data presentations, the ADVANTAGE AF trial for the Farapulse PFA system met its primary endpoints, showing a 2.3% safety event rate and 63.5% effectiveness rate in treating persistent atrial fibrillation (AF) patients, with an 85.3% symptomatic AF recurrence-free rate. Additionally, a sub-analysis of the OPTION trial demonstrated that the Watchman FLX device significantly reduced bleeding outcomes compared to oral anticoagulants.
Boston Scientific Corp.’s OPTION study demonstrated left atrial appendage closure with the Watchman Flx device reduced risk of stroke compared to management with direct oral anticoagulants or warfarin in patients with atrial fibrillation following cardiac ablation. Results were presented at the American Heart Association's Scientific Sessions 2024 and simultaneously published in The New England Journal of Medicine.
New data presented at the Cardiovascular Research Technologies (CRT) 2023 meeting reinforced the safety and effectiveness of Boston Scientific Corp.’s Watchman FLX left atrial appendage occlusion (LAAO) device in routine, real-world clinical care. Building on positive 45-day outcomes presented at CRT 2022, the analysis shows sustained low stroke rate at one year, including ischemic stroke.
Boston Scientific Corp. and Abbott Laboratories continue to parry over clinical trials comparing the latter’s Amplatzer Amulet with Boston Scientific’s Watchman in sealing the heart’s left atrial appendage (LAA) to prevent ischemic stroke in patients with atrial fibrillation (Afib). In one of five presentations at the 34th Transcatheter Cardiovascular Therapeutics annual scientific symposium in Boston in mid-September, Abbott said device-related thrombosis or peri-device leak more frequently preceded strokes in patients with Watchman compared to those with Abbott’s Amplatzer Amulet device.
The race is on. After six years as the only FDA approved devices for left atrial appendage closure, Boston Scientific Corp.’s Watchman products face a challenger, Abbott Laboratories’ Amplatzer Amulet. With the Amulet’s FDA approval in mid-August and positive results in a head-to-head trial presented at the 2021 European Society of Cardiology Congress on Tuesday, the Watchman has reason to look over its shoulder at a competitor that could change the game entirely. The trial results were published simultaneously in Circulation.
The U.S. FDA has been easing gently down the road of real-world evidence (RWE) in regulatory decision-making, and the case of the Watchman left atrial appendage device is instructive in this regard. Robert Shipley, of Boston Scientific Corp. (BSX), said on webinar hosted by the Advanced Medical Technology Association that the FDA changed gears and agreed to a registry for a post-approval study for the first generation Watchman, but added that the use of registry data and other RWE for approval of a next-generation device is as yet more aspirational than practicable.
Boston Scientific Corp. reported positive results for its Emblem subcutaneous implantable defibrillator (S-ICD) system and next-generation Watchman Flx left atrial appendage closure (LAAC) device at the Heart Rhythm Society scientific sessions, which were online only this year due to the COVID-19 pandemic.
