FDA panel offers mixed view on Boston
Scientific Watchman device
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[October 09, 2014]
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.
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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.
Boston Scientific is seeking approval of the device to reduce the
risk of stroke and blood clots in patients with non-valvular atrial
fibrillation who would typically be treated with warfarin, a
standard oral treatment that has some limitations.
The advisory panel has met twice before to discuss the product. In
December 2013, it voted in favor of its safety and efficacy.
However, follow-up clinical trial data showed an additional risk of
ischemic stroke in patients who received the Watchman. The new
information prompted new questions about the device's benefits and
risk and led to Wednesday's meeting.
(Reporting by Toni Clarke in Washington; Editing by Leslie Adler)
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