Edwards Just Scored a Major TAVR Win

Expanded FDA indication for the Sapien 3 marks the first time the agency has approved a TAVR for use in patients who only have intermediate risk of death or complications during surgery. 

Chris Newmarker

FDA on Thursday announced approval of an expanded indication for Edwards Lifescience's Sapien 3 transcatheter aortic valve replacement, providing a major boost to the Irvine, CA-medical device company's efforts to bring the technology to an ever wider audience. 

The expanded indication is for patients with intermediate risk of dying or suffering serious complications during open-heart surgery, defined as a 3% or more chance of dying in the first month after surgery. The Sapien 3 had previously been approved for only high risk patients. 

"This is the first time in the U.S. that a transcatheter aortic valve has been approved for use in intermediate risk patients," said Bram Zuckerman, M.D., FDA cardiovascular device division director, said in a news release.

"This new approval significantly expands the number of patients indicated for this less invasive procedure for aortic valve replacement," Zuckerman said.

Edwards stock ticked up about $2 per share, to roughly $116 per share, in Thursday afternoon trading. 

The expanded indication came after a study of 2005 intermediate-risk patients at 51 U.S. and Canadian sites--about half receiving a Sapien 3 and about half undergoing surgery. The Sapien 3 group showed significantly lower rates of mortality, stroke, and moderate or severe aortic regurgitation after one year, according to Edwards. 

"The Sapien 3 valve has set a new standard for performance and patient outcomes with aortic valve replacement," Vinod Thourani, MD, co-director of the Emory Heart and Vascular Center's Structural Heart and Valve Center, said in an Edwards news release. "The clinical outcomes of 1.1% mortality and 1.0% percent disabling stroke at 30 days in this intermediate-risk population treated with the Sapien valve are changing the paradigm of how we treat patients with aortic stenosis."

The Sapien 3 received its initial FDA approval in 2015. It is the latest version of Edwards's best-selling Sapien valve that first won approval in 2011. The Sapien 3 mostly solves previous leakage issues through a major design change--a skirt at the base of the valve. 

FDA approval of the expanded indication should allow Edwards to be even more competitive against Medtronic, which entered the U.S. transcateter heart valve market in early 2014 with its CoreValve system. Before that, the Sapien had a few years in which it was the only such heart valve available in the United States.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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