Venus Medtech has concluded enrolment of patients in the confirmatory clinical trial for the Venus-PowerX transcatheter aortic valve system in China.
The multi-centre, prospective, objective performance criterion, single-arm Venus-PowerX PREVAILS study is designed to support regulatory submissions in both China and Europe.
It aims to assess the safety, efficacy, and device performance of the Venus-PowerX system in patients diagnosed with severe aortic stenosis.
The device is described as the first self-expanding dry-valve transcatheter aortic valve replacement (TAVR) device with full release and complete retrieval capability after total deployment.
Results from this research are intended to support regulatory applications for CE marking in Europe and approval by the National Medical Products Administration in China.
The Venus-PowerX has already obtained regulatory approvals in Argentina, Chile and Venezuela. It is available commercially in these regions.
Real-world clinical data from Argentina and Chile are being used by Venus Medtech to support broader adoption and continued international expansion.
Venus Medtech chief technology officer Ma Renzheng said: “The successful completion of enrolment in the Venus-PowerX confirmatory trial positions this device as a significant addition to our TAVR portfolio.
“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.”
Venus Medtech develops transcatheter heart valve solutions for structural heart disease and has research and development centres in China, Israel, and the US.
In June 2024, the company completed the first implantation of its VenusP-Valve system in the US as part of the PROTEUS investigational device exemption (IDE) pivotal clinical study.
