FDA Advisory Committee Panel Votes In Favor Of The WATCHMAN™ Left Atrial Appendage Closure Device

Comprehensive Clinical Data from Randomized Trials Reviewed

MARLBOROUGH, Mass. -- After reviewing updated data and analysis for the Boston Scientific Corporation WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee voted in favor of the Device. By a vote of 6 to 5 (with 1 abstention) the Panel concluded that the benefits of the WATCHMAN Device outweigh the potential risks. Furthermore, the Panel voted that there is reasonable assurance that the Device is safe (12 yes to 0 no). On the question of reasonable assurance of effectiveness, the Panel vote was unfavorable (6 yes to 7 no). The Panel provided substantial input and guidance related to the proposed Indications for Use and target patient population. There was widespread agreement among the Panel members that the Device provides a much needed alternative to long-term anticoagulation for some patients. While not bound by this vote, the FDA takes Advisory Panel comments and recommendations into account when reviewing the WATCHMAN Device application. The company is committed to working with the FDA to address the Panel's comments.

"There is a strong clinical need for a proven device alternative to long-term warfarin therapy for my high stroke risk patients with non-valvular atrial fibrillation," said Vivek Reddy, M.D., Director of the Cardiac Arrhythmia Service at Mount Sinai Medical Center and co-principal investigator of the PROTECT AF and PREVAIL studies. "I'm encouraged that the Panel recognized the importance of having the WATCHMAN Device as an option for appropriate patients."

The Committee's positive vote followed a review of the most recent clinical data and analysis from two randomized control trials, PROTECT AF and PREVAIL, as well as from the CAP (Continued Access Protocol) and CAP2 registries. The WATCHMAN Device is the most studied left atrial appendage closure device and the only one with long-term clinical data from over 2,400 patients and nearly 6,000 patient-years of follow-up in clinical studies. The WATCHMAN Device was approved for sale in Europe in 2005 and is currently approved in more than 70 countries across the globe. In the U.S., the WATCHMAN Device is an investigational device, limited to investigational use and not available for sale.

"Today's recommendation by the Panel is another step toward making this innovative technology available to high risk patients with non-valvular atrial fibrillation who are eligible for warfarin, but who have reasons to seek an alternative to long-term therapy," said Kenneth Stein, M.D., Chief Medical Officer, Rhythm Management, Boston Scientific. "We continue to believe that the totality of the data for the WATCHMAN Device provide reasonable assurance of its safety and efficacy as a treatment alternative for these patients. We look forward to our ongoing discussions with FDA."