JENSCARE-B (09877) multiple product combination LuX-Valve Plus TRINITY research, JensClip and Ken-Valve clinical effects released at the American TCT 2025.

JENSCARE-B (09877) announced that the global multi-center clinical trial results of LuX-ValvePlus through transcatheter tricuspid valve replacement (TTVR) system at the 6-month follow-up of the TRINITY trial, as well as the efficiency and safety evidence of the jugular vein access, the one-year follow-up results and application effects of the JensClip for transcatheter mitral valve repair (TMVr) system, and the one-year follow-up results and application effects for the Ken-Valve transcatheter aortic valve replacement (TAVR) system were presented at the 2025 Transcatheter Cardiovascular Therapeutics conference (TCT2025) held in San Francisco, USA. The 6-month clinical follow-up results of the TRINITY study demonstrated the good safety and efficacy performance of LuX-ValvePlus, with continuous improvement in patient quality of life and a stable rate of safety events compared to the 30-day follow-up results, at a low level. LuX-ValvePlus offers a wide range of applications, particularly providing an excellent treatment option for patients with severe tricuspid regurgitation and large annulus, who have limited treatment options. In the TRINITY study, over 75% of enrolled patients used 55mm, 60mm, 65mm, and 70mm large-sized valves. More long-term follow-up data and global clinical research data for LuX-ValvePlus are being accumulated. Currently, LuX-ValvePlus has completed all enrollments in the FDA IDE-EFS in the United States, with a 100% success rate in device operation, excellent safety and efficacy indicators, and the initiation of an FDA pivotal study underway. At the same time, the efficiency and safety evidence of LuX-ValvePlus through jugular vein access was also shared at the TCT conference. The advantages of jugular vein access include a low rate of puncture site bleeding complications, demonstrating superior safety indicators; shorter device operation time, demonstrating higher procedural efficiency; and a low screening failure rate due to jugular vein anatomical structure. Currently, the TRAVELII study and TRINITY study data show bleeding complication rates of 0% and 1.8%, with excellent data results. JensClip is an innovative Innovative Medical Management device designed for the treatment of severe mitral regurgitation, with simple and reliable device operation. Its one-year follow-up results are excellent, with an all-cause mortality rate of only 1.8%, few device-related complications, 96.3% of patients showing no moderate or severe regurgitation, and a continuous improvement in indicators such as New York Heart Association functional class, Kansas City Cardiomyopathy Questionnaire score, and six-minute walk distance. Ken-Valve is an innovative Innovative Medical Management device designed for the treatment of high-risk surgical severe aortic valve regurgitation or mixed aortic valve stenosis dominantly regurgitant patients, with a simple and reliable device operation and wide applicability to complex anatomical structures. Its one-year follow-up results are excellent, with significant improvement in quality of life, stable effective valve area and transvalvular pressure gradient, and a low rate of composite adverse events. Ken-Valve provides six valve ring sizes: 23mm, 25mm, 27mm, 29mm, 31mm, and 33mm. Its unique innovative design and product features applicable to large annulus and transverse heart complex anatomical structures meet the treatment needs of patients with limited treatment options in the current scenario. The company's complete product line research results and clinical application advantages for tricuspid, mitral, and aortic valves at the TCT2025 conference have received high attention and wide praise from global experts and scholars. The company will continue to advance the application and commercial progress of its product portfolio globally, leveraging its successful clinical experience in important regions such as Asia-Pacific, North America, Europe, South America, Australia, the Middle East, excellent clinical performance, unique advanced product design, and diversified product combination.