Venus Medtech Completes Patient Enrollment for Pivotal China TAVR Study
Venus Medtech has concluded patient enrollment for its pivotal Venus-PowerX TAVR system study in China. The data collected will support market approval applications in both China and Europe.
Venus Medtech (Hangzhou) Inc. has announced the completion of patient enrollment for its confirmatory clinical trial of the Venus-PowerX transcatheter aortic valve system. This milestone moves the world's first fully recoverable, self-expanding TAVR system with a dry valve closer to market approval in China and Europe.
The PREVAILS study (Pivotal Study of Severe Aortic Stenosis TREated with the VenusPowerX Transcatheter Aortic Valve System) is a prospective, multicenter, single-arm trial designed to assess the safety, efficacy, and device performance of the Venus-PowerX system in patients with severe aortic stenosis. Data from this study will be used to support simultaneous regulatory submissions for CE Marking in Europe and approval from China's NMPA.
The Venus-PowerX system incorporates several technologies, including 100% retrievability after full deployment, Venus Endura™ Dry tissue with anti-calcification treatment, and a wire-guided release mechanism. The device has already received regulatory approvals in Argentina, Chile, and Venezuela.
Ma Renzheng, Chief Technology Officer at Venus Medtech, stated that the completion of patient enrollment positions the product as a significant addition to the company's TAVR portfolio, with a focus on offering more controllable treatment options for patients with severe aortic stenosis.