FDA Advisory Panel Recommends Approving First-of-its-Kind AFib Device
Heart of Health Policy | An 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 in December to review data from two studies conducted to evaluate the device’s safety and effectiveness, as well patient registry data. At the end of the daylong meeting, the panel voted 13-1 on each of three key questions related to safety, effectiveness and benefit-risk calculus. The FDA will have the final say on if the device will hit the market.
Keywords: Equipment Safety, Registries, Atrial Appendage, United States Food and Drug Administration, Calculi, Advisory Committees, Cardiology Magazine, ACC Publications
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