Medtronic's next-generation Evolut PRO+ TAVR system gains FDA approval for symptomatic severe aortic stenosis

Medtronic announced Monday that the FDA approved the next-generation transcatheter aortic valve replacement (TAVR) system Evolut PRO+ to treat patients with symptomatic severe aortic stenosis. Pieter Kappetein, chief medical officer for the company's structural heart and cardiac surgery businesses, remarked that "in addition to a decrease in profile for the core sizes to help minimise burden on the vessels during the procedure, the Evolut PRO+ TAVR system gives heart teams a familiar technology that's been fine-tuned to help drive excellent patient outcomes."

According to Medtronic, Evolut PRO+ features 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 company noted that sizes include a 34-mm valve that can treat vessels down to 6 mm, while the 23-, 26- and 29-mm valves can treat vessels down to 5 mm. As with the existing Evolut platform, the PRO+ valve is also designed with a self-expanding nitinol frame "that conforms to the native annulus with consistent radial force and advanced sealing," it added.

In August, the FDA expanded the indications for Medtronic's CoreValve Evolut R and CoreValve Evolut PRO TAVR systems, as well as for Edwards Lifesciences' Sapien 3 and Sapien 3 Ultra TAVR systems, to include use in patients with symptomatic severe aortic stenosis at low risk for death or major complications associated with open-heart surgery.

For related analysis, read The Wider View: The heat is on as TAVR playing field opens wide for Edwards, Medtronic.