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

Venus Medtech Achieves Milestone in Venus-PowerX Clinical Trial

Venus Medtech (Hangzhou) Inc., listed under the stock code 02500.HK, has recently announced a significant milestone in the medical device sector. The company has successfully completed patient recruitment for the confirmatory clinical trial of its groundbreaking Venus-PowerX device, a self-expanding dry-valve transcatheter aortic valve replacement (TAVR) system.

This trial, named PREVAILS, is pivotal as it aims to bolster the evidence needed for simultaneous regulatory submissions in both China and Europe for this innovative TAVR system. The Venus-PowerX device boasts a world-first design that allows for 100% retrievability post-deployment, addressing the needs of patients with severe aortic stenosis who require precise and adjustable treatment options.

Key Features of the Venus-PowerX

The Venus-PowerX system stands out from existing TAVR platforms due to its array of advanced features:

• - 100% Recoverable Mechanism: The device can be fully retrieved regardless of its deployment status, offering unmatched flexibility during procedures.
• - Venus Endura™ Dry Tissue: This technology comes with an anti-calcification treatment, which enhances the durability and longevity of the valve.
• - Controlled Release Mechanism: Utilizing a cable-controlled release mechanism ensures precision in deployment.
• - Seadapt™ Adaptive Tissue: This innovation reduces the risk of paravalvular leakage (PVL), improving patient outcomes.
• - V-Shaped Outlet Design: This feature facilitates optimal blood flow and device alignment during procedures.
• - Radiopaque Markers: Three markers help enhance visibility during imaging, making it easier for clinicians to navigate during surgery.

Venus-PowerX has already received regulatory approvals in several Latin American countries, including Argentina, Chile, and Venezuela, marking it as the first commercially available fully recoverable dry-valve TAVR system in the world. The positive clinical data emerging from these regions is significantly underpinning the company’s strategy to introduce Chinese solutions for structural heart diseases to the global market.

Path Forward

The completion of patient recruitment for the Venus-PowerX trial has placed the device in a powerful position for advancing cardiac intervention practices. According to Ma Renzheng, Chief Technology Officer at Venus Medtech, the aim is to provide patients with a more precise, effective, and safe treatment option for severe aortic stenosis. This transition from a 'partially controllable' to a 'fully controllable' mechanism at each stage of the procedure reflects the company's commitment to innovation and patient care.

Venus Medtech continues to be a leader in the development of transcatheter valve solutions for structural heart diseases, with a comprehensive product line including TAVR, transcatheter pulmonary valve replacement (TPVR), transcatheter mitral valve replacement (TMVR), and transcatheter tricuspid valve replacement (TTVR) solutions.

With R&D centers located in China, the United States, and Israel, the company is dedicated to delivering effective treatment solutions for patients facing potentially life-threatening cardiac conditions.

In conclusion, the Venus-PowerX represents a promising advancement in TAVR technology, which could reshape the landscape of heart valve treatments both in China and internationally, pending successful regulatory approvals following the trial's findings.