Venus Medtech completes FIM clinical use of Venus-PowerX, the world’s first fully-released and retrievable dry-tissue valve TAVR system

On December 21st, 2021, Venus Medtech (Hangzhou) Inc. ("Venus Medtech", 2500.HK), a leading comprehensive platform company for innovative structural heart disease treatment in China, announced that its self-developed next-generation transcatheter aortic valve Venus-PowerX, the world’s first fully-released, retrievable and self-expandable dry-tissue valve, completed First-in-Man (FIM) clinical trial at West China Hospital of Sichuan University. Venus-PowerX is another innovative dry-tissue product developed by Venus Medtech, following Venus Vitae, a balloon-expandable dry-tissue valve. The completion of the FIM clinical trial stands as a milestone in consolidating the company's leading position in the field of structural heart disease in China.

The procedure was completed by a multidisciplinary team comprising Professors Chen Mao and Professor Feng Yuan from the Department of Cardiology, Professors Zhu Tao and Professor Chen Guo from the Department of Anesthesiology, and Professor Meng Wei from the Department of Cardiac Surgery at West China Hospital of Sichuan University.

The patient was an 80-year-old male suffering recurrent chest distress and asthma. Ultrasound images indicated severe aortic valve stenosis. After evaluation by the team, the 26mm Venus-PowerX valve was applied. Post-TAVR analysis showed satisfactory outcomes with no perivalvular leakage and central regurgitation in the aortic valve.

Venus-PowerX is Venus Medtech’s next-generation self-expandable dry-tissue TAVR system for the treatment of patients with aortic valve stenosis. Compared with first-gen and second-gen self-expandable valves (VenusA-Valve® and VenusA-Plus®), the new product features a shorter valve frame that offers unique advantages in clinical application. It is worth mentioning that the specially designed dry-tissue valve utilizes an advanced anti-calcification process and is suitable for room temperature storage. The mechanical properties of the valve will not be damaged due to dehydration during the process, which in turn improves valve durability. In addition, the dry-tissue valve can be pre-mounted and contains no aldehyde residue, thereby enhancing safety while facilitating clinical use and valve storage and transport.

At the same time, Venus-PowerX features a unique wire-controlled design that allows for retrieval of the valve after 100% complete release to enhance safety. In addition, its delivery system adopts a new sheath design that optimizes its flexibility to go through the aortic arch. The valve frame is simplified to reserve coronary access with three V-shaped designs while retaining radial force.

Eric Zi, Founder and General Manager of Venus Medtech, said, "In TAVR, valve durability is one of the challenges we have long been working hard on. At Venus Medtech, we started our dry-tissue pipeline in 2016. The successful completion of the FIM clinical trial of Venus-PowerX marks the maturing of our dry-tissue valve technology. We will spare no effort to launch multi-center clinical trials and promote the registration of Venus-PowerX at home and abroad, sharing China’s progress in medical technology and intellectual manufacturing with global doctors and patients.

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