FDA Approves Boston Scientific's Watchman LAA Closure Device

March 13, 2015—Boston Scientific Corporation announced that the US Food and Drug Administration (FDA) has approved the Watchman left atrial appendage closure device as an option for high-risk patients with nonvalvular atrial fibrillation who are seeking an alternative to long-term warfarin therapy. The Watchman device will be made available in the United States to centers involved in Boston Scientific clinical studies, and in additional specialized centers as physicians are trained on the implantation procedure. The Watchman device has been commercially available internationally since 2009.

According to the company, the Watchman device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with nonvalvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS₂ or CHA₂DS₂-VASc scores; are deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a nonpharmacologic alternative to warfarin.

Boston Scientific advised that the FDA approval of the Watchman device is based on the WATCHMAN clinical program, which provided strong evidence that the Watchman device can be implanted safely and reduces the risk of stroke in eligible patients while enabling most patients to discontinue warfarin. Additionally, a meta-analysis of all of the randomized trial data demonstrated that although results of ischemic stroke reduction favored warfarin, the Watchman device provided patients with a comparable protection against all-cause stroke and statistically superior reductions in hemorrhagic stroke, disabling stroke, and cardiovascular death compared to warfarin over long-term follow-up. The WATCHMAN clinical program consists of numerous studies that enrolled more than 2,400 patients and includes approximately 6,000 patient-years of follow-up, noted the company.

Vivek Reddy, MD, serves as coprincipal investigator of the PROTECT AF and PREVAIL studies, which are part of the WATCHMAN clinical program. He is Director of Cardiac Arrhythmia Service at Mount Sinai Medical Center in New York, New York.

In the company's press release, Dr. Reddy commented, "The Watchman device is an important step forward in stroke management for patients with AF. We know that up to 40% of patients who are eligible for oral anticoagulation do not take it for numerous reasons, highlighting the need for additional treatment options. The Watchman device is a breakthrough treatment providing those patients who are suitable for warfarin with an implant-based alternative to long-term warfarin therapy while still reducing the risk of stroke."