#China #TAVR #Hangzhou #Venus Medtech #Venus-PowerX

Venus Medtech Completes Patient Enrollment for Venus-PowerX Trial

Venus Medtech (Hangzhou) Inc. made a significant announcement today, declaring the completion of patient enrollment for its critical clinical trial of the Venus-PowerX Transcatheter Aortic Valve System. This achievement marks a crucial milestone for the world’s first fully recoverable, self-expanding dry-valve TAVR device, bringing it closer to receiving necessary marketing approvals in both China and Europe.

The PREVAILS Study Overview

The clinical trial, known as the PREVAILS study (Pivotal Study of Severe Aortic Stenosis TREated with the Venus‑PowerX TrAnscatheter AortIc VaLve System), is a multicenter, single-arm trial designed to rigorously evaluate the safety and performance of the Venus-PowerX system in patients diagnosed with severe aortic stenosis. Data gathered from this study will be integral in supporting simultaneous regulatory submissions aimed at securing CE marking in Europe and approval from China’s National Medical Products Administration (NMPA).

Innovative Features of Venus-PowerX

The Venus-PowerX device is distinctively equipped with several innovative technologies that set it apart from existing TAVR platforms:

• - Fully Retrievable After Deployment: This includes a unique capability that allows for complete retrieval even after 100% deployment.
• - Venus Endura™ Dry Tissue: Enhanced durability through its specialized anti-calcification treatment.
• - Wire-Controlled Release Mechanism: Facilitates a precise deployment process.
• - Seadapt™ Self-Adaptive Anti-PVL Skirt: Addresses and minimizes the risk of paravalvular leakages.
• - V-Shaped Outflow Design: Optimizes hemodynamics and patient outcomes.
• - Three Radiopaque Markers: Provide enhanced visibility during the procedure.

The Venus-PowerX has already garnered regulatory approvals in various countries, including Argentina, Chile, and Venezuela. This indicates a progressive move to make the world’s first fully recoverable self-expanding dry-valve TAVR device commercially available. Clinical data from these Latin American countries serve as substantial evidence supporting the device's wider clinical adoption.

Commitment to Innovation and Patient Care

“Our successful completion of enrollment in the Venus-PowerX confirmatory trial represents a notable addition to our TAVR product portfolio,” stated Mr. Ma Renzheng, the Chief Technology Officer at Venus Medtech. He emphasized the company’s dedication to enhancing treatment options for patients suffering from severe aortic stenosis, aiming to transition structural heart interventions from being partially controllable to fully controllable throughout every step of the procedure.

Looking Ahead

As the pharmaceutical realm continually evolves, the work Venus Medtech is doing is crucial in advancing cardiovascular treatments. The innovative approach in developing devices like the Venus-PowerX not only highlights the potential for improved patient outcomes but also underscores the company's vision for expanding structural heart solutions across international markets.

In conclusion, the completion of the enrollment phase for the Venus-PowerX trial signifies an exciting time for both Venus Medtech and patients awaiting advanced, reliable treatments for severe aortic stenosis. As they prepare for regulatory submissions in Europe and China, the global health community will be watching closely to see the positive impact this innovative technology can bring to patient care.