Medtronic (NYSE:MDT) announced today that it received CE Mark approval for its Evolut transcatheter aortic valve implantation (TAVI) system.
Evolut TAVI, now commercially launched in Europe, is now indicated for patients with severe native aortic stenosis who are at a low risk of surgical mortality. The system’s indications in Europe now cover all risk categories for severe aortic stenosis patients.
Clinical data from a global, randomized trial that evaluated three valve generations against surgical valve replacement (SAVR) in more than 1,400 patients revealed that TAVI is an effective treatment for low-risk patients, improving 30-day quality-of-life scores compared to SAVR.
Additionally, Evolut displayed superior hemodynamic performance with lower mean aortic valve gradients and larger effective orifice areas compared to surgery at one year.
Medtronic engineered Evolut with a self-expanding nitinol frame that conforms the replacement valve to the native annulus with consistent radial force and includes an external tissue wrap that increases surface area contact with native anatomy for enhanced valve sealing.
The system’s new indication adds to its already cleared status in the U.S., with an indication for symptomatic severe aortic stenosis patients across all risk categories.
“With these approvals, more patients will now be candidates for the Evolut TAVI system while surgical aortic valve replacement will evolve to serve a more complex patient population,” Medtronic VP & chief medical officer for the structural heart & cardiac surgery business Dr. Pieter Kappetein said in a news release. “Medtronic is well positioned to provide a variety of therapy options to meet the varying needs of patients with heart valve disease.”
