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July 27, 2026
Venus Medtech’s PREVAILS Trial for Venus-PowerX TAVR System Completes Enrollment
KEY TAKEAWAYS
- Venus Medtech has completed patient enrollment in the PREVAILS pivotal trial evaluating the Venus-PowerX transcatheter aortic valve system.
- The prospective, multicenter study is designed to assess the safety, efficacy, and device performance of the fully retrievable valve in patients with severe aortic stenosis.
- The data from the trial will support regulatory submissions in Europe and China.
July 27, 2026—China-based Venus Medtech (Hangzhou) Inc. announced that patient enrollment has been completed in its PREVAILS pivotal trial for the Venus-PowerX transcatheter aortic valve (TAVR) system, which is designed to be 100% retrievable after full deployment.
According to the company, PREVAILS is a prospective, multicenter, 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.
Data generated from the study will support simultaneous regulatory submissions for CE Mark approval in Europe and regulatory approval by the National Medical Products Administration in China, advised Venus Medtech.
As outlined in the press release, Venus-PowerX TAVR device’s features include the company’s Venus Endura dry tissue with anticalcification treatment, a wire-controlled release mechanism, a Seadapt self-adaptive antiparavalvular aortic leak skirt, a V-shaped outflow design, and three radiopaque markers.
Currently, the Venus-PowerX is approved in Argentina, Chile, and Venezuela, noted Venus MedTech.
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