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UPDATE: FDA Advisory Panel Votes 13-1 on Benefits of Boston Scientific WATCHMAN Left Atrial Appendage Closure Device

The U.S. FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favorably by a majority, Yes: 13, No: 1, that the benefits of the WATCHMAN Left Atrial Appendage Closure device outweigh the risks.  The FDA Panel was further asked if there is reasonable assurance that the device is safe, the Panel voted Yes: 13, No: 1. On the question of reasonable assurance of efficacy, the Panel voted Yes: 13, No: 1. The FDA will take into account the Panel's vote in its decision on approval of the WATCHMAN device.  The company expects a decision from the FDA in the first half of 2014.

"We are pleased with the outcome of today's Panel, which represents an important milestone toward making this innovative technology available to patients with AF at higher risk for stroke who need an alternative to long-term warfarin therapy," said Kenneth Stein, M.D., Chief Medical Officer, Cardiac Rhythm Management, Boston Scientific. "We appreciate the opportunity to present our comprehensive data supporting the WATCHMAN technology and look forward to continuing discussions with the FDA regarding the Panel's comments."

See full press release

Posted-In: News Guidance Offerings FDA Management Global

 

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