FDA Panel Delivers a Split Vote on Watchman Device

October 9, 2014 9:31 PM

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FDA Panel Delivers a Split Vote on Watchman Device

An FDA advisory committee deliberating upon the risk/benefit ratio on the Watchman left atrial appendage closure device delivered a split vote leaving the future of the device in doubt.

The FDA Circulatory System Devices Advisory Panel gathered to evaluate the Watchman left atrial appendage closure device. The group convened after fresh and updated clinical data from the PREVAIL trial revealed a higher occurrence of ischemic stroke in Watchman subjects who were given short-term war...

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