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Two New Transcatheter Heart Valves Receive FDA Approval
In June, Edwards Lifesciences announced that it received FDA approval for the Sapien 3 balloon-expandable transcatheter heart valve and Medtronic announced that it received approval for the CoreValve Evolut R system, both for the treatment of patients with severe aortic stenosis who are at high risk for surgery.
The Sapien 3 valve has an outer skirt 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 company press release.
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.
The CoreValve Evolut R System is the first recapturable, self-expanding transcatheter heart valve approved in the United States, according to a company press release. The device was built on the foundation of the existing CoreValve system. It includes the Evolut R transcatheter valve, available in sizes of 23 mm, 26 mm and 29 mm, and the EnVeo R delivery system. The Evolut R system also has a smaller profile size, which enables treatment of patients with vessels as small as 5 mm via transfemoral access, according to the release. – by Erik Swain
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. The other is that the delivery profile has been reduced even more, so it goes into a smaller sheath than the current Sapien XT. I think we will see very rapid adoption from Edwards Sapien users.
The Evolut R is a major advance because it is a lower-profile system, 14F, which is slightly lower profile than the Sapien 3 valve. The other great advantage is that it’s recapturable and repositionable.
Both of these systems will help advance the procedure [for patients with aortic stenosis] and make it the norm for aortic valve replacement for people of advanced age. Most doctors think both valves are a major advance, and I think that people who are skilled in this field will develop the ability to use both valves interchangeably.