FDA Approves Medtronic's Next-Generation Evolut Pro+ TAVR System

September 23, 2019—Medtronic announced FDA approval and the United States launch of the company's Evolut Pro+ transcatheter aortic valve replacement (TAVR) system, which builds off the company's self-expanding, supra-annular Evolut TAVR platform.

The Evolut TAVR platform—which includes the Evolut R, Evolut Pro, and Evolut Pro+ TAVR systems—is indicated for patients with symptomatic severe aortic stenosis across all risk categories (extreme, high, intermediate, and low) in the United States. In August, the company announced the FDA’s expanded indication for the Evolut TAVR platform to treat patients at low risk of surgical mortality, the final surgical risk category to be approved for TAVR.

According to Medtronic, the Evolut Pro+ TAVR system includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for a large indicated patient treatment range and low delivery profile. The 23-, 26-, and 29-mm valves can treat vessels as small as 5 mm, and the 34-mm valve can treat vessels as small as 6 mm.

The device features an external tissue wrap and an integrated, inline sheath that allow physicians to treat patients with a range of anatomical variations. 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 valve incorporates an outer porcine pericardial tissue wrap that adds surface area contact and tissue interaction between the valve and the native aortic annulus to help potentially reduce incidences of paravalvular leaks, stated the company.

Mathew R. Williams, MD, who is Director of the Heart Valve Program at NYU Langone Health in New York, New York, commented in Medtronic's announcement, “As TAVR becomes a preferred treatment option for more patients with severe aortic stenosis, it’s critically important to have valve technology available that keeps pace with the evolution of the therapy. Valve technologies that are designed to help minimize paravalvular leak, simplify the valve delivery during the procedure, and for unobstructed blood flow are factors that have made TAVR an excellent choice for many patients.”

Interventional cardiologist Guilherme Attizzani, MD, added, “Physicians are treating a broader range of patient anatomies than ever before—from large to small, from simple to complex. Adding the external tissue wrap to the large 34-mm valve size, which wasn’t previously available, is a major technological improvement that will benefit many patients with larger anatomies.” Dr. Attizzani is Director of the Valve and Structural Heart Disease Center at University Hospitals in Cleveland, Ohio.