Medtronic Announces U.S. Launch Of Evolut PRO+ TAVR System - Quick Facts

(RTTNews) - Medtronic plc (MDT) announced U.S. Food and Drug Administration approval and U.S. launch of the Evolut PRO+ TAVR System - a new-generation Medtronic TAVR 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 company said.