FDA expands indication for Sapien XT, Sapien 3 valves from Edwards Lifesciences

The FDA said today that approved an expanded indication for the Sapien XT and Sapien 3 replacement heart valves for intermediate-risk patients.

Previously, the transcatheter aortic valve replacements were only available for high-risk patients. The FDA approved the Sapien XT device in June 2014 and gave the nod to the Sapien 3 for the high-risk cohort a year later.

“This is the first time in the U.S. that a transcatheter aortic valve has been approved for use in intermediate-risk patients,” cardiovascular devices director Dr. Bram Zuckerman, of the FDA’s Center for Devices & Radiological Health, said in prepared remarks. “This new approval significantly expands the number of patients indicated for this less invasive procedure for aortic valve replacement.”

EW shares were up nearly 2% to $114.92 today in late-day activity.

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