The first implant of its Venus-Vitae TAVR system follows the June implants of the VenusP transcatheter pulmonic valve replacement (TPVR) system.
Hangzhou, China-based Venus Medtech developed its next-generation, balloon-expandable, dry-tissue TAVR system in-house. Prof. So Chak Yu Kent and team at Prince of Wales Hospital performed the two inaugural implantations. The implants, completed in collaboration with Prof. Scott Lim of University of Virginia Medical Center, took place as part of the Venus Medtech Venus-Vitae SMART-ALIGN global multicenter pivotal trial.
Both patients received 23mm Venus-Vitae implants, with investigators reporting good immediate post-operative results. They also reported significant hemodynamic improvement.
Lim said in a news release that Venus-Vitae features the shortest stent frame among current transcatheter aortic valves. He said this encourages him of its potential to treat aortic stenosis while maintaining coronary access. Additionally, Lim lauded its dry valve leaflet technology, which “facilitated rapid preoperative preparation time.”
Following the first two successful implants, Venus Medical plans for SMART-ALIGN to launch progressively across around 20 centers. These centers, spread across Europe, North America and China, anticipate a total of 150 patients with severe aortic stenosis. The company plans to use trial data to support regulatory submissions in the EU, Canada, China and other territories.
“Venus-Vitae is our next generation balloon-expandable TAVR system, with global patent coverage,” said Hou-Sen Lim, GM and CEO of Venus Medtech. “We have strong confidence in its international multi-center clinical trials and global strategy. The successful initial implantations provide a solid foundation for forthcoming trials in Europe, North America, and China. We are committed to advancing Vitae’s global clinical application and regulatory registration, bringing our cutting-edge technology to physicians and patients worldwide.”
