FDA Advisory Panel Recommends Approving First-of-its-Kind AFib Device
A U.S. Food and Drug Administration (FDA) advisory committee has overwhelmingly recommended approval of the Watchman Left Atrial Appendage Closure Technology. The FDA’s Circulatory System Devices Panel convened on Dec. 11 to review data from two studies conducted to evaluate the device’s safety and effectiveness, as well patient registry data. The panel was asked by the FDA to provide a recommendation “regarding whether or not the data demonstrate a reasonable assurance of safety and effectiveness, and whether the probable benefits of the device outweigh the probable risks.” The FDA stressed: “It is critical that Advisory Panel members review the totality of data in making these determinations as each component of the dataset has strengths and limitations.” At the end of the day-long meeting, the panel voted 13-1 on each of three key questions: safety, effectiveness and benefit-risk calculus.
This week’s advisory panel review of the device wasn’t the first. Back in 2009, an FDA advisory committee reviewed results from the PROTECT AF trial and recommended that the Agency approve the device. However, the FDA did not take the panel’s advice, instead requesting another study to evaluate the device. Hence, the FDA worked with the device’s manufacturer to design the PREVAIL trial. This second trial narrowly missed meeting its primary endpoint, that the 18-month rate of stroke, systemic embolism and cardiovascular or unexplained death was non-inferior to warfarin.
According the FDA, Boston Scientific, manufacturer of the first-of-its-kind transcatheter left atrial appendage closure device, has proposed that the Watchman be indicated for reducing the risk of stroke and systemic embolism in warfarin-eligible patients with non-valvular atrial fibrillation.
Check out the ACC’s Advocacy Twitter Feed (@Cardiology) for live coverage from the committee meeting.
Keywords: Advisory Committees, Atrial Appendage, Atrial Fibrillation, Embolism, Registries, Risk Assessment, Stroke, United States Food and Drug Administration, Warfarin
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