Medtronic’s Evolut Pro+ TAVR System Approved in Europe

May 3, 2021—Medtronic announced CE Mark approval of the Evolut Pro+ transcatheter aortic valve replacement (TAVR) system. The Evolut Pro+ includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for a large annular range.

According to the company, 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+ system is approved in four valve sizes: the 23-, 26-, and 29-mm systems can access vessels down to 5 mm, and the 34 mm system can access vessels down to 6 mm.

The Evolut Pro+ 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. It includes an integrated inline sheath, allowing physicians to treat patients with a range of anatomic 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, stated Medtronic.

“As TAVR expands to a broader patient population, including patients at a low risk of surgical mortality and those with bicuspid valves, having the right valve technology becomes a critically important factor in making treatment decisions,” commented Haim Danenberg, MD, in Medtronic’s press release. “Heart teams pursue a valve solution that is safe, effective, and durable. We need a system that can be delivered through the femoral arteries without losing any feature of efficacy, such as reducing paravalvular leak and achieving excellent hemodynamics. Because of its design and long track record of exceptional clinical outcomes, the Evolut TAVR platform is well suited to meet these needs.” Dr. Danenberg is Professor of Medicine and Head of Interventional Cardiology at Wolfson Medical Center in Holon, Israel.

Nicolas Van Mieghem, MD, added, “Anatomic variations can present unique challenges and demand tailored transcatheter valve selection. This is the first time European physicians will have access to the large 34-mm Evolut Pro+ valve size that contains an external tissue wrap for patients with large aortic root dimensions.” Dr. Van Mieghem is Professor of Interventional Cardiology at Erasmus University Medical Center in Rotterdam, the Netherlands.

The Evolut TAVR platform—including the Evolut R, Evolut Pro, and Evolut Pro+ TAVR systems—is indicated for symptomatic severe native aortic stenosis patients across all surgical risk categories (extreme, high, intermediate, and low) in the United States and countries that recognize CE Mark, advised Medtronic.