FDA NewsPerspective

FDA approves recapturable transcatheter aortic heart valve

Medtronic announced that it has received FDA approval for a new recapturable, self-expanding system for transcatheter aortic valve replacement for treatment of patients with severe aortic stenosis who are at high or extreme risk for surgery.

The CoreValve Evolut R System (Medtronic) device 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 system is designed to increase conformability and sealing at the annulus, as well as improve blood flow and hemodynamic performance. 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.

Mathew R. Williams, MD

Mathew Williams

“In a short time, the TAVR procedure has become an established treatment option for high-risk patients with severe aortic stenosis who are unable to undergo surgery, and physicians are looking to technology advancements to help deliver even better patient outcomes,” Mathew Williams, MD, chief of adult cardiac surgery and director of interventional cardiology and structural heart at NYU Langone Medical Center, said in the release. “The advancement of recapturability with Evolut R gives physicians more confidence during the procedure.”

Disclosure: Williams reports serving as a consultant for and receiving research funding from Medtronic.

Medtronic announced that it has received FDA approval for a new recapturable, self-expanding system for transcatheter aortic valve replacement for treatment of patients with severe aortic stenosis who are at high or extreme risk for surgery.

The CoreValve Evolut R System (Medtronic) device 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 system is designed to increase conformability and sealing at the annulus, as well as improve blood flow and hemodynamic performance. 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.

Mathew R. Williams, MD

Mathew Williams

“In a short time, the TAVR procedure has become an established treatment option for high-risk patients with severe aortic stenosis who are unable to undergo surgery, and physicians are looking to technology advancements to help deliver even better patient outcomes,” Mathew Williams, MD, chief of adult cardiac surgery and director of interventional cardiology and structural heart at NYU Langone Medical Center, said in the release. “The advancement of recapturability with Evolut R gives physicians more confidence during the procedure.”

Disclosure: Williams reports serving as a consultant for and receiving research funding from Medtronic.

    Perspective
    James Slater

    James Slater

    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 (Edwards Lifesciences), because you can usually get a lower profile with a self-expanding valve than with a balloon-expandable valve.

    The other great advantage of the Evolut R valve is that it’s recapturable and repositionable. If you start to put it in and don’t like where it is, you can recapture and reposition it to put it in a better place. That’s a capability that a self-expanding valve system has that a balloon-expandable system doesn’t. When you make a decision about the Sapien 3 valve, and you expand that balloon, that’s it. It will go where it goes and you can’t do anything about it.

    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.

    • James Slater, MD, FACC
    • Director of cardiac cath lab, NYU Langone Medical Center

    Disclosures: Slater reports no relevant financial disclosures.