Jianshi Technology-B (09877) multi-product combination LUX-Valve Plus TRINITY study, Jensclip, and clinical effects of KEN-Valve were released in TCT 2025

Zhitong Financial App News, Jianshi Technology-B (09877) announced that recently, the results of the 6-month global multicenter clinical trial (TRINITY) of the LUX-Valve Plus transvascular tricuspid valve interventional replacement (TTVR) system and evidence of the efficiency and safety of transjugular access, one-year follow-up results and challenging case application results of the JensClip transvascular mitral valve repair (TMVR) system, as well as one-year follow-up results and case applications of the Ken-Valve transcatheter aortic valve replacement (TAVR) system The results were presented at the 2025 Transcatheter Cardiovascular Academic Conference (TCT2025) held in San Francisco, USA.

The 6-month clinical follow-up results of the Trinity study showed the good safety and efficacy of LUX-Valve Plus. The patient's quality of life continued to improve, and the incidence of safety incidents remained stable and low compared to the 30-day follow-up results. LUX-ValvePlus has a wide range of applications, particularly providing excellent treatment options for large valve ring patients in severe tricuspid valve reflux patients. This patient group's choices in current clinical treatment methods are very limited. In the TRINITY study, over 75% of enrolled patients used 55mm, 60mm, 65mm, and 70mm large valves. LUX-VALVEPlus's longer-term follow-up data and global clinical research data are continuing to accumulate. At present, LUX-Valve Plus has completed full enrollment in FDAIDE-EFS in the US. The device's operating power has reached 100%, the safety and efficacy indicators are excellent, and the FDA's pivotal clinical study (PivotalStudy) is about to begin.

At the same time, evidence on the efficiency and safety of LUX-Valve Plus transjugular access was shared at this TCT conference. The advantages of transjugular access include lower incidence of bleeding at the puncture site, which reflects better safety indicators; shorter instrument operation time, which reflects higher surgical operation efficiency; and lower screening rate due to jugular vein anatomy. The current TRAVELII study and TRINITY study data show that the bleeding complication rates are 0% and 1.8%, respectively, and the data results are excellent.

JensClip is an innovative medical device designed to treat severe mitral valve reflux. The device is easy to operate and reliable. The one-year follow-up results were excellent. Among them, the all-cause mortality rate was only 1.8%, and there were only a few device-related complications. 96.3% of patients showed no moderate or higher reflux, and continued improvement in indicators such as New York cardiac function level, Kansas City cardiomyopathy questionnaire score, and six-minute walking distance.

Ken-Valve is an innovative medical device designed to treat patients with severe aortic valve regurgitation or mixed aortic stenosis with a high surgical risk. The device is easy to operate and reliable, and is suitable for a wide range of anatomical structures. The one-year follow-up results were excellent, the quality of life improved markedly, the effective valve area and cross-valve pressure difference remained stable, and the incidence of complex adverse events remained low. KEN-Valve can provide six valve ring sizes of 23mm, 25mm, 27mm, 29mm, 31mm, and 33mm. Its unique and innovative design and product features that can be applied to complex challenging anatomical structures such as large valve rings and transverse centers can meet the treatment needs of patients with limited existing treatment methods.

The multiple research results and clinical application advantages of the company's entire product line covering the tricuspid valve, mitral valve, and aortic valve received great attention and widespread praise from experts and scholars from around the world at the TCT 2025 conference. The company will continue to promote the application and commercialization of the company's product portfolio on a global scale, relying on numerous successful clinical application experiences, excellent clinical performance, unique and advanced product design, and diversified product portfolios in important countries and regions around the world, including Asia Pacific, North America, Europe, South America, Australia, and the Middle East.