Medtronic (NYSE:MDT) announced today that it received CE mark approval for its next-generation Evolut Pro+ TAVI system.
Fridley, Minn.-based Medtronic’s Evolut Pro+ transcatheter aortic valve implantation (TAVI) system is the newest version of the company’s self-expanding, supra-annular Evolut Tavi platform.
The latest edition of the platform includes four valve sizes with an external pericardial tissue wrap for advanced sealing with the largest annular range, according to a news release.
Medtronic said the approval follows an indication expansion for Evolut in Europe that extends to patients with severe aortic stenosis who are at low risk for surgical mortality and patients with bicuspid aortic valves who are at intermediate, high and extreme risk of surgical mortality.
Evolut Pro+ TAVI’s valve sizes are 23 mm, 26 mm and 29 mm for accessing vessels down to 5 mm, along with the 34 mm system for accessing vessels down to 6 mm. The system’s porcine pericardial tissue wrap adds surface area contact and tissue interaction between the valve and the native aortic annulus, Medtronic said.
Additionally, the system includes an integrated, inline sheath designed to allow physicians to treat patients with a range of anatomical variations with a low delivery profile. Like Evolut versions before it, the Pro+ valve has a self-expanding nitinol frame designed to conform to the native annulus with consistent radial force and advanced sealing.
“We believe that continued iteration of the CoreValve/Evolut family of supra-annular transcatheter aortic valves will result in progressive improvements in patient outcomes,” Medtronic VP & CMO for the coronary & renal denervation business Dr. Jeffrey J. Popma, M.D. said in the release. “The Evolut Pro+ TAVI system will provide heart teams a valve with strong hemodynamic performance, with a lower vascular access profile, thereby allowing more patients to be treated by a transfemoral approach rather than alternative access methods. The additional pericardial wrap in the 34 mm Evolut Pro+ may also reduce the degree of residual perivalvular regurgitation.”