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The FDA transcatheter aortic valve for inoperable and high-surgical-risk aortic valve stenosis.
The Sapien 3 valve is the first in the series to feature a skirt at the base of the valve to seal gaps and reduce paravalvular leakage. The original Sapien valve was approved in 2011.
"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," , acting director of the Office of Device Evaluation at FDA's Center for Devices and Radiological Health said in a release announcing the approval.
In the , 30-day results showed a 3.7% rate of moderate leak and 0.1% severe leak compared with typically 10% to 20% rates of moderate to severe paravalvular leak with currently approved devices.
Intermediate-risk results from that trial are due out on the Sapien 3 and second-generation device likely at next year's American College of Cardiology meeting.
The approval comes about 3 months earlier than expected and ahead of competitor Medtronic's next generation Evolut R device, a Wells Fargo Securities equity research report pointed out.
From the American Heart Association: