Boston Scientific (NYSE:BSX) and its Watchman anti-stroke device are next month slated for their 3rd appearance before an FDA advisory panel, the safety agency said today.
Two prior meetings of the Circulatory System Devices panel resulted in approval recommendations for the Watchman device. Despite the 1st panel's 2009 positive vote, the FDA in March 2010 issued a "not approvable" letter for Watchman, a transcatheter implant designed to reduce the risk of stroke by closing off the heart's left atrial appendage.
A 2nd panel voted 13-1 last year that the Watchman implant meets safety and efficacy goals.
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