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FDA looks favourably on Watchman device

On December 11, 2013, an advisory panel of the Food and Drug Administration (FDA) voted favourably by a majority of 13 to 1 to approve a left atrial appendage (LAA) closure device (Watchman™, Boston Scientific) for stroke prevention in patients with atrial fibrillation (AF) in the United States.

The FDA’s Circulatory System Devices panel convened yesterday to discuss the safety, efficacy and risk-benefit of the device. A decision by the FDA is expected in the first half of 2014.

The device aims at reducing the risk of stroke in patients with AF by permanently closing off the LAA, and thereby avoiding the migration of emboli to the brain. Currently, the device is available in 55 countries worldwide and was commercialised outside the United States in 2009. In the US, it is still an investigational device, limited by applicable law to investigational use only and not available for sale.

The vote of the committee followed a review of clinical data from two randomised control trials, PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) and PREVAIL (Randomized Trial of LAA Closure vs Warfarin for Stroke/ Thromboembolic Prevention in Patients with Non-valvular Atrial Fibrillation), as well as from the CAP (Continued Access Protocol) registry.

Published on: December 20, 2013

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ENDORSED BY

  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association
 

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