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.”
“The intermediate-risk approval of the Sapien 3 valve is a major milestone, since it provides a less-invasive therapy that has demonstrated better outcomes for aortic valve patients, and is supported by the largest and rigorous comparative body of evidence for the treatment of aortic stenosis,” added Edwards transcatheter heart valves vice president Larry Wood.
Dr. Vinod Thourani of Emory University, co-principal investigator in the Sapien 3 trial, said the device “set a new standard for performance and patient outcomes with aortic valve replacement.”
“The clinical outcomes of 1.1% mortality and 1.0% disabling stroke at 30 days in this intermediate-risk population treated with the Sapien 3 valve are changing the paradigm of how we treat patients with aortic stenosis,” Thourani said.
EW shares closed up 2.0% at $114.95 today.