JENSCARE-B Multi-product portfolio LuX-Valve Plus TRINITY research, JensClip and Ken-Valve clinical results to be released at TCT 2025 in the United States

According to the Zhitong Finance APP, JENSCARE-B (09877) announced that recent global multicenter clinical trial (TRINITY) results for the LuX-ValvePlus transcatheter tricuspid valve replacement (TTVR) system at the 6-month follow-up, as well as evidence of efficiency and safety for the transjugular approach, the one-year follow-up results for the JensClip transcatheter mitral valve repair (TMVr) system and its application in challenging cases, and the one-year follow-up results for the Ken-Valve transcatheter aortic valve replacement (TAVR) system and its application in challenging cases were presented at the 2025 Transcatheter Cardiovascular Therapeutics (TCT2025) conference held in San Francisco, USA.

The 6-month follow-up results of the TRINITY study demonstrated the good safety and efficacy profile of LuX-ValvePlus, with continuous improvement in patients' quality of life and a stable incidence of adverse events compared to the 30-day follow-up results, remaining at a low level. LuX-ValvePlus offers an excellent treatment option for patients with severe tricuspid regurgitation, particularly for those with large annuli, a group that currently has very limited treatment options. In the TRINITY study, over 75% of enrolled patients used 55mm, 60mm, 65mm, and 70mm large-sized valves. Long-term follow-up data and global clinical research data for LuX-ValvePlus are continuously being accumulated. Currently, the FDA IDE-EFS for LuX-ValvePlus in the United States has completed all enrollments, with a device operation success rate of 100%, and excellent safety and efficacy indicators, with the pivotal clinical study about to be launched.

At the same time, evidence of the efficiency and safety of the LuX-ValvePlus via the transjugular approach was also shared at this TCT conference. The advantages of the transjugular approach include a lower rate of puncture site bleeding complications, reflecting superior safety indicators; shorter device operation time, reflecting higher procedural efficiency; and a lower failure rate due to the anatomical structure of the jugular vein. Current data from the TRAVEL II and TRINITY studies show bleeding complication rates of 0% and 1.8%, respectively, demonstrating excellent results.

JensClip is an innovative medical device designed for the treatment of severe mitral regurgitation, with simple and reliable operation. Its one-year follow-up results are outstanding, with an all-cause mortality rate of only 1.8%, and only a few device-related complications, with 96.3% of patients showing no moderate or greater regurgitation, along with continuous improvements in indicators such as New York Heart Association functional classification, Kansas City Cardiomyopathy Questionnaire scores, and six-minute walk distance.

Ken-Valve is an innovative medical device designed for the treatment of high-surgical-risk patients with severe aortic regurgitation or mixed aortic stenosis primarily due to regurgitation, featuring simple and reliable operation and applicability to a wide range of anatomical structures. Its one-year follow-up results are excellent, with significant improvements in quality of life, stable effective orifice area and transvalvular pressure gradient, and a low rate of composite adverse events. Ken-Valve is available in six annulus sizes: 23mm, 25mm, 27mm, 29mm, 31mm, and 33mm, with a unique innovative design applicable to large annuli The product characteristics of complex challenges in horizontal heart positioning can meet the treatment needs of patients with large valve rings, where existing treatment methods are relatively limited.

This time, the company's comprehensive research results and clinical application advantages covering the full product line of tricuspid valve, mitral valve, and aortic valve have received high attention and widespread acclaim from global experts and scholars at the TCT2025 conference. The company will rely on a wealth of successful clinical application experience, excellent clinical performance, unique advanced product design, and a diversified product portfolio in important countries and regions worldwide, including Asia-Pacific, North America, Europe, South America, Australia, and the Middle East, to continuously promote the application and commercialization progress of the company's product portfolio globally