#TAVR #Venus Medtech #Venus-PowerX

Major Milestone Reached: Completion of Patient Recruitment for Venus-PowerX Study

Venus Medtech (Hangzhou) Inc. has officially announced the completion of patient recruitment in the significant clinical study known as the PREVAILS trial for its innovative Venus-PowerX Transcatheter Aortic Valve Replacement (TAVR) system. This event marks an essential step forward in the development and potential commercialization of what is touted as the world’s first fully retrievable and self-expanding TAVR system featuring a dry valve. As the healthcare industry continues to evolve, innovations like the Venus-PowerX promise to enhance patient treatment for severe aortic stenosis.

A Breakthrough in Cardiac Care

The Venus-PowerX system stands apart from existing TAVR technologies by incorporating multiple state-of-the-art features. Notably, it can be entirely removed after full deployment, presenting a unique advantages over its counterparts. Moreover, it utilizes Venus Endura™ Dry Tissue, which is treated to prevent calcification, thereby offering enhanced durability and efficiency during procedures. Other attributes include a wire-controlled release mechanism and a self-adjusting anti-paravalvular leak (PVL) collar, designed for optimal performance and patient safety.

The PREVAILS study was specifically designed to assess the safety, efficacy, and performance of the Venus-PowerX system in patients diagnosed with severe aortic stenosis. This prospective, multi-center, single-arm study employs objective performance criteria, and the data collected will not only support the application processes for CE marking in Europe but also regulatory approval through the China NMPA.

Insights From Previous Markets

Before reaching this pivotal point in China, the Venus-PowerX system achieved regulatory approvals in several Latin American countries, notably Argentina, Chile, and Venezuela. These early approvals have positioned the Venus-PowerX as a commercially available product, bolstered by clinical data from real-world applications that support its broader use. Such evidence is crucial for Venus Medtech's strategy to introduce effective solutions for structural heart diseases to the international market.

Ma Renzheng, Chief Technology Officer of Venus Medtech, highlighted the significance of this recruitment milestone, stating, “The successful conclusion of patient recruitment for the Venus-PowerX confirmation study positions this product as a significant addition to our TAVR portfolio. We are committed to providing patients with severe aortic stenosis a more precise, safer, and better-controllable treatment option.” This sentiment underscores the company's dedication to enhancing the intervention of structural heart disease treatments to ensure they transition from