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Another Advisory Panel For Watchman Yields Another Mixed Result

The market prospects for Boston Scientific’s Watchman left-atrial appendage closure device for stroke remain uncertain following a narrow vote in favor of the device’s risk-benefit profile by FDA’s Circulatory System Devices Advisory Panel even though a majority of the panel did not believe the clinical data proved the device is effective.

The third FDA advisory panel to review Boston Scientific Corp.’sWatchman left-atrial appendage closure device for stroke prevention voted narrowly in favor of the device on the assumption that FDA and the company can figure out a more restrictive indication for it and devise a plan to carefully manage its dissemination.

At its October 8 meeting, FDA’s Circulatory System Devices panel generally agreed that the clinical data do not show that Watchman is superior or even equivalent to therapy with the...

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