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Next-generation balloon-expandable TAVR system receives FDA approval
Edwards Lifesciences announced that the FDA has approved its Sapien 3 balloon-expandable transcatheter aortic heart valve for the treatment of high-risk patients with severe, symptomatic aortic stenosis.
The Sapien 3 valve has an outer skirt — a cuff surrounding the valve frame — to provide a seal to help prevent paravalvular leak, and is available in 20-mm, 23-mm, 26-mm and 29-mm sizes, according to a press release from Edwards.
The device was approved based on data from a cohort of 583 high-risk patients from 29 U.S. sites in the PARTNER II trial, according to the release.
Martin B. Leon
“The Sapien 3 valve sets a new standard for transcatheter heart valve performance and patient outcomes,” Martin B. Leon, MD, director of the Center for Interventional Vascular Therapy at New York-Presbyterian/Columbia University Medical Center; professor of medicine at Columbia University College of Physicians and Surgeons; and co-principal investigator of the PARTNER II trial, said in the release. “The PARTNER II study concluded that this new valve reduced several complications associated with the [transcatheter aortic valve replacement] procedure such as paravalvular leakage and stroke, and represented a meaningful improvement over data from prior studies with earlier-generation devices.”
Perspective
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The Sapien 3 is definitely an advance in terms of the technology incorporated into the valve. There are two new features of note. One is that it has a sealing skirt surrounding it that reduces quite dramatically the incidence of paravalvular leak, which has been one of the Achilles’ heels of stent valve technologies. So that’s a big advance. The other is that the delivery profile has been reduced even more, so it goes into a smaller sheath than the current Sapien XT. These are both important developments.
Those who are comfortable using the Sapien and Sapien XT valves now — and a large number of hospitals use those widely — will immediately adopt the Sapien 3 because it is a superior valve, they will get better results, and most likely they will have fewer complications with it. I think we will see very rapid adoption from Edwards Sapien users.
Because of this approval and that of the CoreValve Evolut R (Medtronic), it’s a great time for people in the United States with aortic stenosis. Both of these systems will help advance the procedure and make it the norm for aortic valve replacement for people of advanced age.