Boston Scientific Study Shows New Device Simplifies Post-Implant Care

MARLBOROUGH, Mass. and SAN DIEGO, Nov. 2, 2026 /CourierPR/ -- Boston Scientific Corporation announced positive six-month primary endpoint results from the SIMPLAAFY randomized controlled trial of the WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device at Transcatheter Cardiovascular Therapeutics® (TCT®) 2026, the annual scientific symposium of the Cardiovascular Research Foundation® (CRF®). The study evaluated two single-drug regimens as alternatives to dual anti-platelet therapy (DAPT) following implantation of the device in patients with non-valvular atrial fibrillation (NVAF). Key results were presented and simultaneously published in JAMA.

The WATCHMAN FLX™ Pro device used in the trial is intended to protect against strokes caused by blood clots that form in the left atrial appendage (LAA) in people with NVAF who need an alternative to long-term blood thinners, and includes HEMOCOAT Technology™, which is designed to enable more controlled, faster healing following implantation. The SIMPLAAFY trial is assessing whether the device, with the addition of HEMOCOAT, may continue to offer similar rates of stroke protection and reduce early bleeding when paired with less-intensive post-implant regimens, and will follow patients through 12 months.

For patients with NVAF who undergo an LAAC procedure, balancing short-term bleeding risk with the need to maintain stroke protection during post-procedure healing is critical. The findings from the SIMPLAAFY trial are encouraging and highlight the potential to meaningfully simplify post-procedure care and reduce medication burden for patients following WATCHMAN FLX Pro implantation.

The study randomized 1,857 patients across 86 clinical study sites in the U.S. to a post-implant regimen of aspirin alone for the duration of the trial or reduced-dose non-vitamin K antagonist oral anticoagulant (NOAC) for the first three months followed by aspirin only or a DAPT regimen of aspirin and clopidogrel antiplatelet medication for the first six months, followed by aspirin only. At six months, data demonstrated that the aspirin alone and reduced-dose NOAC alone regimens each achieved noninferiority to DAPT, with patients on these regimens experiencing less bleeding and equivalent ischemic stroke rates to DAPT (0.7%). Additionally, imaging at 45 days also showed the rate of device-related thrombus, or clotting, was lowest in the patients on a reduced-dose NOAC compared to DAPT (0.9% vs. 3.4%; P=0.01).

With more than two decades of clinical evidence, the WATCHMAN implant has helped reduce stroke risk for more than 800,000 patients worldwide. The current-generation WATCHMAN FLX Pro device was approved by the U.S. Food and Drug Administration in 2023. Enrollment in the Elite AF trial, evaluating the safety and efficacy of the next-generation WATCHMAN Elite™ LAAC Device, commenced in 2026.

Boston Scientific Corporation transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, Boston Scientific provides a broad range of high-performance devices and therapies that address unmet patient needs and reduce the cost of healthcare. The company's portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological, and urological diseases and conditions.