Boston Scientific faces more questions over Watchman implant's effectiveness, risks

December 9, 2013 by Arezu Sarvestani

Healthcare regulators will take a closer look at missed efficacy endpoints and surgical risks associated with Boston Scientific's Watchman anti-stroke heart implant, which is slated this week to undergo FDA advisory panel review.

Boston Scientific faces more FDA questions over Watchman heart implant's risks

Boston Scientific (NYSE:BSX) may have to confront some tough questions when it faces a panel of FDA experts reviewing its Watchman stroke-preventing heart implant.

In panel documents released ahead of this week's meeting, the FDA asked its advisory committee to keep in mind that the Watchman permanent left atrial appendage closure device failed in a recent study to meet a primary goal for effectiveness and that previous trials have raised questions about the risks surrounding implantation surgery.

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The Watchman implant, already available in 30 countries, is introduced via catheter and threaded into the heart to close off the left atrial appendage and capture any blood clots that may form there.

A December 11 meeting of the FDA's Circulatory System Devices Panel will discuss whether the Watchman device is safe and effective enough to recommend for FDA approval. Although the FDA is not bound by the recommendations of its advisory panels, it often follows their lead.