The PREVAILS study, now with completed patient recruitment, marks a key step toward simultaneous regulatory submissions in China and Europe for the next-generation TAVR system

/PRNewswire/ -- Venus Medtech (Hangzhou) Inc. (02500.HK) announced today that patient recruitment for the confirmatory clinical study of the Venus-PowerX transcatheter aortic valve system has concluded. This milestone advances the world's first self-expanding TAVR system with a dry valve, which can be fully released and retrieved even after 100 percent deployment, closer to market approval in China and Europe.

The Venus-PowerX PREVAILS study (Pivotal Study of Severe Aortic Stenosis Treated with the VenusPowerX Transcatheter Aortic Valve System) is a prospective, multicenter, single-arm trial using objective performance criteria to assess the safety, efficacy, and device performance of the Venus-PowerX system in patients with severe aortic stenosis. Data from this study will support simultaneous regulatory filings for CE marking in Europe and approval by China's NMPA.

Venus-PowerX integrates several innovative technologies that set it apart from current TAVR platforms:

100 percent retrievable after full deployment
Venus Endura Dry tissue with anti-calcification treatment
Wire-guided release mechanism
Seadapt self-adapting anti-PVL skirt
V-shaped outflow design
Three radiopaque markers

Venus-PowerX has already secured regulatory approvals in Argentina, Chile, and Venezuela, making it the world's first commercially available fully retrievable self-expanding TAVR product with a dry valve. Real-world clinical data from Latin America, especially Argentina and Chile, provide evidence supporting broader clinical use and the company's strategy to bring Chinese solutions for structural heart disease to international markets.

"The successful completion of patient recruitment for the Venus-PowerX confirmatory study positions this product as a major addition to our TAVR portfolio," said Ma Renzheng, Chief Technology Officer of Venus Medtech. "We aim to offer patients with severe aortic stenosis a more precise, safer, and better controlled treatment option while advancing interventional therapy for structural heart disease from partially controllable to fully controllable at every procedural step."

About Venus Medtech

Venus Medtech (Hangzhou) Inc. (2500.HK) is a leading innovator in transcatheter heart valve solutions for structural heart disease. The company has built a comprehensive product pipeline covering all four heart valves - TAVR, TPVR, TMVR, and TTVR - along with related accessory products. With global research and development centers in China, the United States, and Israel, the company focuses on delivering effective treatment solutions for life-threatening conditions.