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News From the Food and Drug Administration
April 21, 2015

Device Approved for Some Patients With Atrial Fibrillation

JAMA. 2015;313(15):1507. doi:10.1001/jama.2015.3001

Patients with atrial fibrillation who are at high risk for stroke now have an alternative to long-term warfarin therapy.

The Food and Drug Administration (FDA) has approved a device called the WATCHMAN (see image), which is designed to close the left atrial appendage and prevent blood clots from migrating to the brain and causing a stroke. Boston Scientific, the device manufacturer, announced FDA approval in mid-March. The agency had twice before declined to approve the device, which is intended for patients with nonvalvular atrial fibrillation, because of safety and efficacy concerns (http://on.wsj.com/1F2QEtK).

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