Venus Medtech Completes Patient Enrollment in Chinese Heart Valve Trial
Venus Medtech announced the completion of patient enrollment in a pivotal trial for its novel heart valve system. Data generated will support regulatory submissions in China and Europe.
Venus Medtech (Hangzhou) Inc. announced on July 23, 2026, the completion of patient enrollment in its confirmatory clinical trial for the Venus-PowerX Transcatheter Aortic Valve System.
The PREVAILS study marks a critical step toward seeking market approval for the heart valve system in China and Europe. The data from this study will be used to support simultaneous regulatory submissions for CE marking in Europe and approval by China's National Medical Products Administration (NMPA).
The Venus-PowerX system is a self-expanding transcatheter aortic valve replacement (TAVR) device designed to be fully retrievable, even after 100% deployment. This feature differentiates it from existing TAVR platforms. The device incorporates several technical innovations, including dry tissue technology, intended to enhance safety and efficacy for patients with severe aortic stenosis.
Venus-PowerX has already received regulatory approvals in Argentina, Chile, and Venezuela, becoming the world's first commercially available fully recoverable self-expanding dry-valve TAVR product. The company aims to bring Chinese structural heart solutions to international markets.