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 confo…