PREVAILS evaluates the safety, efficacy and performance of the valve in severe aortic stenosis (AS). The company plans to use findings to support simultaneous regulatory submissions for CE Mark and China’s NMPA approval.
Hangzhou, China-based Venus Medtech said the milestone brings its TAVR system one step closer to market approval for the world’s first self-expanding dry-valve TAVR device capable of full release and complete retrieval—even after 100% deployment— in China and Europe.
The company’s 100% retrievable valve includes its Endura dry tissue material with anti-calcification treatment. It also has a wire-controlled release mechanism and Seadapt self-adaptive anti-paravalvular leak (PVL) skirt. The valve features a v-shaped outflow design and three radiopaque markers as well.
Venus-PowerX already has regulatory approval in Argentina, Chile and Venezuela, Venus Medtech said. Further regulatory approvals would boost the company’s portfolio, which also includes transcatheter tricuspid valve replacement (TTVR) technology. It also has a balloon-expandable TAVR system and more.
Ma Renzheng, chief technology officer of Venus Medtech, said:
“The successful completion of enrollment in the Venus-PowerX confirmatory trial positions this device as a significant addition to our TAVR portfolio. We are committed to offering patients with severe aortic stenosis a more precise, safer, and more controllable treatment option, and to advancing structural heart intervention from ‘partially controllable’ to ‘fully controllable’ at every step of the procedure.”
