A Food and Drug Administration (FDA) advisory panel specializing on circulatory system devices has voted overwhelmingly to recommend approval to Boston Scientific’s Watchman left atrial appendage closure device designed to prevent strokes in patients who suffer from a common irregular heart rhythm condition known as atrial fibrillation. The panel agreed in three separate 13-1 votes that the device was effective, safe, and that the benefits out weighed the risks.
The FDA is not required to follow the advice of its expert panels, however it usually does. And, the agency is expect to approve the device. The big question is whether the agency will allow the Watchman to enter the United States market in the second half of 2014.
It has been a long and somewhat checkered road for the Watchman. Earlier this year the American College of Cardiology canceled a presentation unveiling data from a major clinical trail after it was revealed that Boston Scientific had broken an embargo in 2010 by giving the results to investors.
The major concern, and the primary reason why one of the 14 panelists voted against recommending the Watchman for approval, was the potential for the device to be overused. The committee also agreed that the device did not prove more effective than the blood thinner warfarin, the standard treatment for atrial fibrillation.
There was also concern that the device was not pitted against newer classes of anticoagulants, such as Pradaxa. Those drugs can put users at risk for major bleeding events. Based on the data, the panel could not establish if the Watchman was associated with a lower risk of major bleeding or ischemic stroke than warfarin therapy.
While it is likely that the FDA will approve the device, these concerns may limit the indication for the Watchman.