- 3rd FDA panel vote barely favors Boston Scientific’s Watchman anti-stroke device
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An FDA advisory panel offered a mixed view of Boston Scientific’s Watchman heart device earlier this month, 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 1 abstention, that the benefits outweigh the risks, with some panelists saying it should be an option for patients.
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Source: www.massdevice.com; October 13, 2014.