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FDA panel offers mixed view on Boston Scientific Watchman device

Started by riky, October 09, 2014, 09:00:52 AM

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riky

FDA panel offers mixed view on Boston Scientific Watchman device

WASHINGTON (Reuters) - An advisory panel to the U.S. Food and Drug Administration offered a mixed view of Boston Scientific Corp's Watchman heart device on Wednesday, concluding it is probably safe but not particularly effective in reducing the risk of stroke in patients with a certain type of irregular heart beat. Despite the lack of likely effectiveness, the panel voted 6-5, with one abstention, that the benefits outweigh the risks, with some panelists saying it should be an option for patients. The FDA is not obliged to follow the advice of its advisory panels but typically does so. ...

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