May 4, 2021 – Medtronic plc (Dublin, Ireland) announced CE Mark of the Evolut PRO+ TAVI System – the newest-generation Medtronic TAVI system that builds off the self-expanding, supra-annular Evolut TAVI platform.
The Evolut PRO+ TAVI System includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for the largest annular range (for self-expanding TAVI technology) on the market.
The approval follows a recent indication expansion for the Evolut platform in Europe for patients with severe aortic stenosis who are at a low risk of surgical mortality and patients with bicuspid aortic valves who are at intermediate, high and extreme risk of surgical mortality.
The Evolut PRO+ TAVI System is approved in four valve sizes (the 23, 26 and 29mm systems can access vessels down to 5.0 mm) with the 34 mm system able to access vessels down to 6.0 mm.
The system is designed with an outer porcine pericardial tissue wrap that adds surface area contact and tissue interaction between the valve and the native aortic annulus, and includes an integrated, inline sheath, allowing physicians to treat patients with a range of anatomical variations with a low delivery profile.
Consistent with the Evolut platform design, the PRO+ valve is designed with a self-expanding nitinol frame that conforms to the native annulus with consistent radial force and advanced sealing.
The Evolut TAVR platform, including the Evolut R, Evolut PRO and Evolut PRO+ TAVI Systems, is indicated for symptomatic severe native aortic stenosis patients across all surgical risk categories (extreme, high, intermediate and low) in the U.S. and countries that recognize CE Mark.