Venus Medtech Completes Patient Enrollment in Pivotal China Trial for Venus-PowerX TAVR System

Venus Medtech (Hangzhou) Inc. announced the completion of patient enrollment for its confirmatory clinical trial of the Venus-PowerX Transcatheter Aortic Valve System in China. This development marks a significant step for the company, moving it closer to simultaneous market approval submissions in both Europe and China.

The PREVAILS study, a prospective, single-arm, multicenter trial, aims to evaluate the safety, efficacy, and performance of the Venus-PowerX system in patients with severe aortic stenosis. Data from this trial will support concurrent applications for CE marking in Europe and regulatory approval from China's National Medical Products Administration (NMPA).

The Venus-PowerX system incorporates several novel technologies distinguishing it from current TAVR platforms. These include 100% retrievability post-full deployment, a dry-tissue Venus EnduraTM valve with anti-calcification treatment, a cable-driven deployment mechanism, and SeadaptTM technology to mitigate paravalvular leakage.

The device has already received regulatory approvals in Argentina, Chile, and Venezuela, positioning it as the world's first commercially available fully retrievable, self-expanding dry-valve TAVR system. Real-world clinical data from Latin America supports broader clinical adoption and the company's strategy to commercialize its structural heart disease solutions internationally.

"The successful completion of patient enrollment for the Venus-PowerX confirmatory trial represents a significant addition to our TAVR product portfolio," stated Ma Renzheng, Chief Technology Officer at Venus Medtech. "We are committed to providing patients with severe aortic stenosis a more precise, safer, and easier-to-manage treatment option."