Venus Medtech completes patient recruitment for Venus-PowerX clinical trial

Venus Medtech announced the completion of patient recruitment for the confirmatory clinical trial of its Venus-PowerX transcatheter aortic valve system (TAVR). This milestone brings the world's first fully repositionable, self-expanding dry-valve TAVR device closer to commercial approval in China and Europe.

The Venus-PowerX is designed with a significant feature: it is 100% retrievable after full deployment, meaning it can be repositioned or completely removed even after it has been fully opened. This capability distinguishes it from previous models and a number of competing devices currently on the market. The successful completion of this trial is a crucial step toward gaining regulatory clearance.

The PREVAILS study is a prospective, multicenter, single-arm trial designed to assess the safety, efficacy, and performance of the Venus-PowerX system in patients with severe aortic stenosis. The data generated will support simultaneous regulatory submission applications for CE marking in Europe and for approval by China's NMPA. The device has already received regulatory approvals in Argentina, Chile, and Venezuela.

Venus Medtech has stated that it is generating real-world clinical data from Latin America supporting the company's strategy to introduce Chinese structural heart disease solutions into international markets. According to Chief Technology Officer Ma Renzheng, Venus-PowerX aims to provide a more precise, safe, and controllable treatment option for patients experiencing severe aortic stenosis.