Venus Medtech has announced that patient enrolment has been completed in its confirmatory clinical trial for the Venus-PowerX transcatheter aortic valve implantation (TAVI) system.
The Venus-PowerX PREVAILS study is a prospective, multicentre, single-arm, objective‑performance‑criterion trial designed to evaluate the safety, efficacy, and device performance of the Venus-PowerX system in patients with severe aortic stenosis. Venus Medtech describes the device as the first self-expanding dry-valve TAVI device capable of full release and complete retrieval.
Data generated from the study will support simultaneous regulatory submissions for CE marking in Europe and regulatory approval by China’s National Medical Products Administration (NMPA).
Venus-PowerX has already secured regulatory approvals in Argentina, Chile, and Venezuela.
“The successful completion of enrolment in the Venus-PowerX confirmatory trial positions this device as a significant addition to our TAVI 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.”
