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FDA Panel Backs Anti-Stroke Device

Approval decision expected in first half of 2014 (December 11)

By a majority vote (13 to 1), the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favorably that the benefits of the Watchman Left Atrial Appendage Closure device (Boston Scientific) outweigh its risks.

The panel members were further asked whether there is reasonable assurance that the device is safe, and they again responded with 13 “yes” votes and one “no” vote. On the question of reasonable assurance of efficacy, the panel also voted Yes: 13, No: 1.

The FDA will consider the panel’s recommendations in its decision on approval of the Watchman device. The agency is expected to make its decision 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, thereby reducing the incidence of stroke and systemic embolism for higher-risk patients with nonvalvular atrial fibrillation (AF). The LAA is a thin, sack-like appendix arising from the heart and is believed to be the source of most stroke-causing blood clots in patients with AF.

The device is commercially available in more than 55 countries, and more than 7,000 implants have been performed worldwide. In the U.S., it is an investigational device and is not available for sale.

Source: PR Newswire; December 11, 2013.

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