FDA widens use of Edwards devices for heart valve replacement
The U.S. Food and Drug Administration has widened the use of Edwards Lifesciences Corp's heart valves to patients at intermediate risk of complications if they underwent open heart surgery.
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.
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 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.