GAITHERSBURG, MD — At long last, the US Food and Drug Administration (FDA) has approved the Watchman (Boston Scientific) left atrial appendage closure device for the prevention of stroke in patients with atrial fibrillation (AF).
After three trips before the FDA's Circulatory System Devices Panel and 6 years after the results of first Watchman trial—PROTECT-AF—were presented at the American College of Cardiology 2009 Scientific Sessions, the device is approved for reducing the risk of thromboembolism in high-risk patients with nonvalvular AF. The device is meant to be an option for high-risk patients seeking an alternative to warfarin.
According to Boston Scientific, the Watchman will be available in US centers involved in the Watchman clinical-trial program and other specialized centers that receive training on device implantation. The Watchman has been available outside the US since 2009.
At the most recent FDA advisory meeting in 2014, the committee voted unanimously that the device was safe for the proposed indication but were split on the device's efficacy and whether or not the benefits of the Watchman outweighed the risks. In the end, as reported by heartwire on Medscape, the panel voted 7 votes to 6 that the device was effective and 6 votes to 5 that the benefits outweighed the risks.
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Cite this: FDA Approves Watchman for Stroke Prevention in AF Patients - Medscape - Mar 14, 2015.