FDA: is it time for the Watchman?

Following its promising debut in the PROTECT-AF trial a few weeks ago at the ACC, the Watchman device appears likely to receive a somewhat less ecstatic response when it appears before the FDA’s Circulatory System Devices Panel on Thursday. The Watchman is an implantable device that blocks the left atrial appendage with a fabric-covered expandable nitinol cage. It is designed to help patients with nonvalvular AF avoid warfarin therapy.

The FDA briefing documents suggest that  difficult questions will be raised at the hearing about the patient population that has been studied with the device, the duration of treatment they received, and the use of concomitant warfarin by some patients.

You can read Reuters, MedPage Today, and Heartwire news reports about the briefing documents.

You can read the FDA briefing documents here.

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  1. […] You can read links to additonal coverage about the device in our previous story. […]

  2. […] presentation of the PROTECT AF trial. Despite a positive reception at the ACC, the Watchman received somewhat more critical reviews from the FDA staff, though it eventually received a positive, though hardly unanimous, vote of approval from the […]

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