Boston Scientific Corporation May Face A Tough FDA Panel

Published: Dec 11, 2013

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On Wednesday the FDA’s Circulatory System Devices Panel will once again review Boston Scientific's BSX -1.19% Watchman left atrial appendage closure device for the prevention of stroke in atrial fibrillation patients (click here for the meeting materials). The panel will be the latest chapter in the long and contentious story of the Watchman. In 2010 the FDA issued a complete response letter and earlier this year a scandal broke out when the American College of Cardiology cancelled a prestigious late-breaking clinical trial presentation of the PREVAIL trial after the company broke an embargo by giving trial results to investors.

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