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

Mon, 12/09/2013 - 3:00pm
Mass Device

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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