Medtronic Announces FDA Approval and U.S. Launch of Next-Gen EVOLUT PRO+ TAVR System for Treatment of Symptomatic Severe Aortic Stenosis Patients

Medtronic plc announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Evolut PRO+ TAVR System ­— a new generation system that builds off the self-expanding, supra-annular Evolut TAVR platform. The Evolut PRO+ TAVR System includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for the largest indicated patient treatment range and the lowest delivery profile currently on the market. The launch comes on the heels of the FDA’s recent indication expansion for the Evolut TAVR platform to treat patients with symptomatic severe aortic stenosis at a low risk of surgical mortality, the final surgical risk category to be approved for TAVR.

The Evolut PRO+ TAVR System can treat the broadest annulus range and offers the lowest delivery profile on the market (the 23-, 26- and 29-mm valves can treat vessels down to 5.0 mm). It features four valve sizes — including the 34 mm (treats vessels down to 6.0 mm) — with an external tissue wrap and an integrated, inline sheath. 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 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.

“Physicians are treating a broader range of patient anatomies,“ said Guilherme Attizzani, MD, interventional cardiologist and director of the Valve and Structural Heart Disease Center at University Hospitals in Cleveland, Ohio. ”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.” 

The Evolut TAVR platform, including the Evolut R, Evolut PRO and Evolut PRO+ TAVR Systems, is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low) in the United States.