On December 16th, 2021, Venus Medtech (Hangzhou) Inc. ("Venus Medtech", 02500.HK), a leading comprehensive platform company for innovative structural heart disease therapies in China, announced the completion of the first two implantations in the First-in-Man (FIM) clinical trial of Venus Vitae, its self-developed next-generation balloon-expandable dry-tissue transcatheter aortic valve, in Argentina. This commenced the global clinical application of the company’s next-generation TAVR product and marked a milestone in its journey of innovation.

The two procedures were completed by a team led by Professor Jorge Alberto Baccaro from Instituto De Cardiologia in Corrientes, Argentina, in collaboration with Professor Rehman from Genesis Heart & Vascular Group in Ohio, USA.

Case 1

85-year-old female patient suffering aortic valve stenosis with moderate calcification. Valve ring 24.7 mm. A 26 mm Venus Vitae valve was implanted in less than one hour. Postoperative CEUS showed no central or paravalvular leakage. Blood pressure returned to normal. The transvalvular pressure gradient was 4 mmHG.

Case 2

88-year-old male patient suffering aortic valve stenosis with severe calcification. Valve ring 26.0 mm. A 26 mm Venus Vitae valve was implanted within 40 minutes. Postoperative CEUS showed no central or paravalvular leakage. Blood pressure returned to normal. The transvalvular pressure gradient was 2 mmHG.

 

Venus Vitae is the next-generation balloon-expandable dry-tissue valve TAVR product developed by Venus Medtech for the treatment of patients with aortic valve stenosis. Unlike self-expandable valves, the balloon-expandable valve has a shorter valve frame, which presents a unique advantage in clinical applications. The dry-tissue valve can be preserved at room temperature, and the mechanical performance of the valve will not be damaged during preservation, which indicates better durability.

 

Compared with its international counterparts, Venus Vitae adopts advanced anti-calcification technologies to improve valve durability. The specifically designed dry tissue can be pre-mounted and contains no residual aldehyde, making it easier for clinical application as well as storage and transport. In addition, its patented wire lock technology can ensure the valve does not shift on the balloon catheter. The design of golden radiopaque markers on the locking wire can effectively assist the operator in precise positioning. Meanwhile, the product utilizes a supra-annular design, as well as a short valve frame and a smaller diameter delivery system, which ensures an increased flexibility to go through the aortic arch.

 

Eric Zi, Founder and General Manager of Venus Medtech, said "The successful completion of the first two FIM cases of Venus Vitae will expedite the commercialization of the product. Vitae features multiple international patents and a unique design, which lays a solid foundation for its global commercialization. Venus Medtech has been committed to becoming a global leader in structural heart disease treatment, pursuing the vision of innovation and globalization. We will make every effort to promote the clinical trials and registration of Vitae in China and abroad, bringing cutting-edge technology to more doctors and patients around the world."