New data from a clinical trial of Boston Scientific’s (NYSE:BSX) Watchman anti-stroke device, presented last week at the annual Transcatheter Cardiovascular Therapies conference, showed no efficacy benefit in reducing the risk of stroke compared with the anti-coagulant warfarin
The Watchman device is scheduled for a 3rd appearance before the FDA’s Circulatory System Devices advisory panel Oct. 8, when the panel will consider the new data.
The panel has voted twice to approve the device, which is designed to reduce the risk of stroke by closing off the heart’s left atrial appendage, but the FDA has yet to make a final decision on Boston Scientific’s pre-market approval bid.
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