U.S. FDA panel backs use of Boston Scientific anti-stroke device
(Reuters) – An advisory panel of medical experts voted on Wednesday to recommend that U.S. health regulators approve an experimental stroke-prevention device made by Boston Scientific Corp The panel voted 13 to 1 that the benefits outweigh the risks of the Watchman device. The committee advised the U.S. Food and Drug Administration to approve the Watchman for the prevention of ischemic stroke and systemic embolism in patients with a dangerous cardiac rhythm known as atrial fibrillation. People with atrial fibrillation, the most common type of arrhythmia, are five times more likely to suffer a stroke than those without the condition. The FDA typically follows the recommendations of its expert advisory panels, but is not obligated to do so.