Venus Medtech (Hangzhou) Inc, a prominent leader in transcatheter structural heart valvular therapies in China, is thrilled to announce the successful completion of the first two implantations of its next-generation balloon-expandable dry-tissue transcatheter aortic valve replacement (TAVR) system, Venus-Vitae. This achievement signifies the launch of the Venus-Vitae SMART-ALIGN pivotal clinical trial, which is being carried out at Prince of Wales Hospital in Hong Kong, China.
Advancing Transcatheter Valve Technology
The Venus-Vitae SMART-ALIGN trial is a significant step forward in the realm of dry-tissue valve technology. Designed to assess the safety and effectiveness of the Venus-Vitae TAVR system, this trial aims to address severe aortic stenosis with a cutting-edge solution. The successful implantation of the first two devices highlights the promising potential of the Venus-Vitae system in advancing heart valve replacement procedures.
Following these initial successes, the SMART-ALIGN trial will expand across approximately 20 centers in Europe, North America, and China. A total of 150 patients are expected to be enrolled, with the trial data being used to support regulatory registration applications in various international markets, including the EU, Canada, and China.
Collaborative Success in Clinical Procedures
The procedures at Prince of Wales Hospital were performed by Prof. So Chak Yu Kent and his team, in partnership with Prof. Scott Lim from the University of Virginia Medical Center. Both patients received 23mm Venus-Vitae implants, and the outcomes were highly promising, showcasing significant hemodynamic improvement and excellent immediate post-operative results.
“Prof. Scott Lim shared his excitement, saying, ‘After the successful implantation in the VenusP-Valve PROTEUS pivotal trial in the U.S., it has been a privilege to work alongside Dr. Kent on this important step forward.So on these initial Venus-Vitae procedures. These implantations mark significant progress for both the VenusP Valve and the Venus-Vitae valve. The Venus-Vitae valve’s innovative stent frame design and dry valve leaflet technology are particularly noteworthy for treating aortic stenosis while preserving coronary access.”
Future Prospects and Innovations
Prof. So Chak Yu Kent shared his excitement about the outcomes, saying, “Collaborating with Dr. Scott Lim on these groundbreaking implantations was a privilege. Venus-Vitae’s advanced anti-PVL technology and compact frame design effectively minimize leakage and reduce the risk of coronary artery obstruction. We are optimistic about the swift enrollment of patients, which will enable more individuals to benefit from this state-of-the-art technology in the near future.”
Hou-Sen Lim, General Manager and CEO of Venus Medtech, voiced strong confidence in the future of Venus-Vitae, noting, “Venus-Vitae represents our next-generation balloon-expandable TAVR system with comprehensive global patent protection. The success of these initial implantations provides a solid foundation for the forthcoming trials in Europe, North America, and China. We are dedicated to advancing Venus-Vitae’s global clinical application and regulatory registration, ensuring our innovative technology reaches physicians and patients around the world.”
Enhancing Global Impact
The Venus-Vitae SMART-ALIGN clinical trial is a pivotal moment for Venus Medtech, marking significant progress in the development of advanced transcatheter heart valve solutions. The trial’s success underscores the potential of the Venus-Vitae system to address severe aortic stenosis with a focus on innovation and patient outcomes. As the trial expands, Venus Medtech remains committed to enhancing the global impact of its cutting-edge technology, bringing valuable solutions to the forefront of cardiovascular care.