Medtronic (NYSE:MDT) said today it won FDA approval for its CoreValve Evolut R 34mm transcatheter aortic valve replacement system, touting it as the largest sized TAVR system available in the U.S.
The Fridley, Minn.-based company said the system is cleared for use in patients with severe aortic stenosis and who are at high or extreme risk for surgery, with an annulus size between 26 and 30mm.
Medtronic claims that the large valve segment is estimated to account for 25-30% of the TAVR patient population.
“We’re pleased to have more options to offer patients suffering from severe aortic stenosis who are at high risk or unable to have open-heart surgery. This new, larger valve offers patients with larger anatomical structures access to TAVR. For physicians, the recapturable and repositionable Evolut R can lead to increased accuracy in placement and control during the procedure,” Evolut 34mm clinical study co-primary investigator Dr. Mathew Williams of the NYU Langone Medical Center said in prepared remarks.
The Evolut R 34mm is designed to be delivered with the company’s EnVeo R delivery catheter system and fits within the native aortic valve with a self-expanding nitinol frame.
“Heart teams can now use the Evolut R platform to treat the broadest annulus range in the U.S. market. The approval of the 34mm valve expands the patient population that can now receive this minimally invasive treatment alternative to open heart surgery. We look forward to working with physicians and heart teams across the U.S. to provide this valve to the many patients who need it,” Medtronic heart valve therapies biz veep & GM Rhonda Robb said in a press release.
The CoreValve Evolut R 34mm only has approval in the U.S. at this time, the company said, and is not yet approved in Europe or other countries.
In August, Medtronic said it won expanded CE Mark approval in the European Union for its CoreValve Evolut R transcatheter aortic valve replacement, now approved for aortic stenosis patients at intermediate risk for open-heart surgery.
The company touted the win, saying it is the 1st TAVR system to have received expanded indication in Europe for patients at intermediate risk for open heart surgery.
