Medtronic today announced that it received National Medical Products Administration approval in China for its CoreValve Evolut Pro TAVR system.
The approval marks the first Medtronic TAVR system approved in China for patients with symptomatic severe aortic stenosis who are at high or extreme risk for open-heart surgery, according to the company.
Medtronic’s approval of the self-expanding TAVR system is based on clinical data from more than 32,000 patients, which showed high survival, low rates of stroke, minimal paravalvular leak and excellent hemodynamics. The company plans to do a full commercial launch in early 2022.
Evolut Pro TAVR is the next generation of the company’s supra-annular CoreValve Evolut R system that provides hemodynamic performance. The Pro TAVR is recapturable and repositionable with a self-expanding nitinol frame and an outer wrap that adds surface area contact between the valve and the native aortic annulus for valve sealing.
“We are excited to introduce the Medtronic supra-annular, self-expanding and recapturable TAVR platform to physicians and their patients in China as we look to expand access to our technology in new geographies,” Nina Goodheart, president of structural heart and aortic business in Medtronic cardiovascular portfolio, said in a news release. “We have a tremendous opportunity to positively impact many patients with severe aortic stenosis in China.”