Venus Medtech (Hangzhou) Inc. has completed patient enrollment in the pivotal PREVAILS clinical trial for its Venus-PowerX Transcatheter Aortic Valve System, marking a major milestone for the company’s next-generation transcatheter aortic valve replacement (TAVR) technology.

 

The completion of enrollment moves Venus-PowerX closer to potential regulatory submissions in China and Europe for what the company describes as the world’s first fully recoverable self-expanding dry-valve TAVR system — a device designed to allow complete release and retrieval even after full deployment.

 

The Venus-PowerX PREVAILS study is a prospective, multicenter, single-arm clinical trial evaluating the safety, effectiveness, and performance of the system in patients with severe aortic stenosis. Data from the trial will support regulatory submissions for CE marking in Europe and approval by China’s National Medical Products Administration (NMPA).

 

Venus Medtech said the system is designed to address key challenges in current TAVR procedures through a range of advanced technologies.

 

The Venus-PowerX system has already received regulatory approvals in Argentina, Chile, and Venezuela, making it the first commercially available fully recoverable self-expanding dry-valve TAVR product, according to the company.

 

Clinical experience from Latin America, particularly Argentina and Chile, is generating real-world evidence that Venus Medtech says will support broader adoption of the technology and strengthen its efforts to expand Chinese-developed structural heart solutions globally.

 

"The successful completion of enrollment in the Venus-PowerX confirmatory trial positions this device as a significant addition to our TAVR portfolio," said Ma Renzheng, Chief Technology Officer of Venus Medtech. 

 

"We are committed to offering patients with severe aortic stenosis a more precise, safer, and more controllable treatment option, and to advancing structural heart intervention from 'partially controllable' to 'fully controllable' at every step of the procedure."