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 The devices, Sapien XT and Sapien 3, have already been approved for
use in patients unlikely to survive open-heart surgery or are at
high risk for complications. (http://bit.ly/2b49uXI)
Heart valve replacement is performed to improve blood flow in
patients suffering from severe aortic valve stenosis, a condition in
which the aortic valve opening narrows.
The U.S. health regulator said on Thursday it had also asked the
company for a post-approval study to further monitor the safety and
effectiveness of the devices in previously treated patients for 10
years.
Shares of the Irvine, California-based medical device maker closed
up 2 pct at $114.95 on Thursday.
(Reporting by Dipika Jain in Bengaluru; Editing by Maju Samuel)
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