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 the FDA briefing documents here.