FDA Advisory Panel Votes Favorably on Boston Scientific's Watchman LAA Closure Device

December 11, 2013—Boston Scientific Corporation (Natick, MA) announced that the US Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favorably that the benefits of the company's Watchman left atrial appendage (LAA) closure device outweigh the risks (Yes: 13, No: 1). The FDA panel also voted favorably that there is reasonable assurance that the device is safe (Yes: 13, No: 1) and that there is reasonable assurance of efficacy (Yes: 13, No: 1).

Boston Scientific advised that the FDA will take into account the panel's votes in its decision on approval of the Watchman. The company expects a decision from the FDA in the first half of 2014.

The Watchman device is a catheter-delivered heart implant designed to close the LAA in order to prevent the migration of blood clots from the LAA and thus reduce the incidence of stroke and systemic embolism for higher-risk patients with nonvalvular atrial fibrillation (AF). The device offers a treatment for patients with AF at higher risk for stroke who need an alternative to long-term warfarin therapy, stated the company.

According to Boston Scientific, the vote of the committee followed a review of clinical data from two randomized, controlled trials (PROTECT AF and PREVAIL) and from the CAP (Continued Access Protocol) registry. Studies of the Watchman LAA closure device have provided long-term clinical data from 2,000 patients and approximately 4,900 patient-years of follow-up in clinical trials.

The Watchman device received European CE Mark approval in 2005 and approval in some Asian countries in 2009. It is currently available in more than 55 countries. In the United States, Watchman is an investigational device, limited to investigational use, and not available for sale. The device was developed by Atritech, Inc. (Plymouth, MN), which Boston Scientific acquired in March 2011.