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Edwards Gets FDA Approval for Latest Sapien Valve

The Sapien 3 mostly solves previous leakage issues through a major design change--a skirt at the base of the valve.

Edwards Sapien 3
Sapien 3 (Image courtesy of Edwards Lifesciences)
Chris Newmarker
FDA on Wednesday said it has approved Edwards Lifesciences' Sapien 3 transcatheter heart valve, the latest version of its best-selling Sapien valve that first won approval in 2011.
The Sapien 3 should help Edwards better compete 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.
Such valves are implanted through a transcatheter procedure and are meant for patients with with aortic valve stenosis who are too weak or advanced in age to undergo an open-heart surgery. 
The Sapien 3 has a major design change in that it adds a skirt at the base of the valve to minimize leakage around the valve. A clinical study involving 583 patients with aortic valve stenosis, and at high risk for open heart surgery, found leakage around the Sapien 3 valve in only 3% of cases after 30 days, down from 14.3% for the original Sapien.
"Clinical data showed that the Sapien 3 transcatheter heart valve is superior to the first generation Sapien transcatheter heart valve, with significantly less leakage through and around the valve," said William Maisel, MD, acting director of the Office of Device Evaluation at FDA's Center for Devices and Radiological Health.
Edwards Lifesciences stock shot up more than 4%, to more than $143 per share, in after-hours trading Wednesday amid the news. 
Edwards also received a boost in competition with Medtronic last year when it won a legal patent disputes fight over transcatheter heart valves. Medtronic agreed to pay Edwards a $750 million payment upfront--and between $320 million and $480 million in license royalty payments over the next eight years--to settle all pending cases or appeals in courts and patent offices around the world.
Refresh your medical device industry knowledge at MEDevice San Diego, September 1-2, 2015.

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

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