Atriech's Watchman, a percutaneously implanted left atrial appendage occlusion device, won the recommendation of a FDA advisory panel on April 23, for its ability to protect against stroke in patients with non-valvular atrial fibrillation.
The circulatory system devices panel voted 7 to 5 in favor of the Watchman device, a fabric-covered nitinol cage developed to prevent embolization of thrombi that form in the left atrial appendage in patients with atrial fibrillation.
The approval came with several stipulations, such as the unexpected decision that the device should be approved in warfarin-eligible patients only.
The caveat appears to stem from the design of the device's pivotal premarket approval study PROTECT-AF, said Maggie Wallner, vice president of clinical marketing and education at the Plymouth, Minn.-based Atritech. To be eligible for the trial, patients must have been able to take warfarin and also able to stop taking warfarin if they were randomized to the device group.
The FDA is not bound by the panel's recommendation, but the agency follows the panel's advice in most cases.