FDA Advisory Committee recommends Watchman LAA device to prevent clots that cause Stroke-Boston Scientific
The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favourably by a majority, Yes: 13, No: 1, that the benefits of the Watchman Left Atrial Appendage Closure device from Boston Scientific, outweigh the risks. The FDA Panel was further asked if there is reasonable assurance that the device is safe, the Panel voted Yes: 13, No: 1. On the question of reasonable assurance of efficacy, the Panel voted Yes: 13, No: 1. The FDA will take into account the Panel's vote in its decision on approval of the Watchman device. The company expects a decision from the FDA in the first half of 2014.
The Watchman device is a catheter-delivered heart implant designed to close the left atrial appendage (LAA) in order to prevent the migration of blood clots from the LAA, and thus, reduce the incidence of stroke and systemic embolism for higher risk patients with non-valvular AF.
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