China’s Venus Medtech completes first implantations of its in-house TAVR system

Venus Medtech, a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced that its in-house developed next-generation balloon-expandable dry-tissue transcatheter aortic valve replacement (TAVR) system, Venus-Vitae, successfully completed two inaugural implantations as part of its global multicenter pivotal trial, Venus-Vitae SMART-ALIGN, at Prince of Wales Hospital in Hong Kong, China.

Venus-Vitae utilizes the innovative Venus-Endura technology, which integrates multiple anti-calcification techniques, immunogenicity removal technology and 3D force-controlled dehydration technology, providing enhanced durability, biocompatibility, and anti-calcification performance. In addition, this design allows for room temperature storage of the valve in a dry-tissue condition.

Additionally, the product features a unique patented technology, Lockwire Technology, ensuring the stability and accuracy of the valve during delivery and deployment. The short stent frame of Venus-Vitae's valve along with its steerable NAVIMASTER delivery system, significantly optimizes the performance across the aortic arch and positioning within the native valve. Venus-Vitae also features a unique Coronary Alignment technology, addressing the fundamental challenge that current TAVR products have been unable to address—aiding in protection of the coronary arteries. By utilizing three gold markers at the base of the valve leaflets in conjunction with the delivery system's steering, telescoping, and balloon rotation capabilities, Venus-Vitae can effortlessly and precisely achieve coronary alignment during the deployment process. This aids in accomplishing coronary protection throughout the implantation procedure.

Furthermore, Venus-Vitae features a self-adaptive anti-PVL technology, utilizing an adaptive polymer skirt. The proprietary polymer skirt material possesses a high compression ratio, excellent resilience, self-expanding properties, and adaptive sealing. It demonstrates adaptive deformation during valve crimping, without enlarging the profile of the delivery system. Upon deployment, it actively fills the gaps around the valve perimeter, achieving remarkable anti-PVL performance.

Following the first two successful implantations, Venus-Vitae SMART-ALIGN pivotal clinical trial will be progressively launched at around 20 centers in Europe, North America and China, enrolling a total of 150 patients. The trial data will be used to support registration applications in the EU, Canada, China and other territories.