JENSCARE-B (09877) announced that the 6-month clinical follow-up results for large annulus patients in the global multicenter clinical trial (TRINITY) of the LuX-Valve Plus transcatheter tricuspid valve replacement system, as well as the 1-year clinical follow-up results of Ken-Valve in large annulus patients, were presented at the 2025 London Valve Conference. The findings highlight the company's product advantages in large-size applications, demonstrating its potential to address broad and unmet clinical needs.

**LuX-Valve Plus TRINITY Study: 6-Month Clinical Follow-Up Results for Large Annulus Patients** The TRINITY study is a global, prospective, multicenter, single-arm clinical trial designed to evaluate the safety and efficacy of LuX-Valve Plus in patients with severe tricuspid regurgitation (TR) who are at high surgical risk. The study enrolled 161 patients across 20 centers worldwide, including 18 centers in France, Germany, Spain, Denmark, and the UK.

Severe TR patients often present with right heart and tricuspid annular dilation, which complicates interventional treatment. Large annulus patients have limited safe and effective treatment options, representing a significant unmet clinical need.

LuX-Valve Plus offers seven valve sizes ranging from 40mm to 70mm. In the TRINITY study, over 75% of patients received valves sized 55mm, 60mm, 65mm, or 70mm. The average age of these patients was 77 years, with a mean Tri-Score of 13.5%. Baseline data showed 10.7% of patients had severe TR, 47.1% had massive TR, and 42.2% exhibited torrential TR.

The 6-month follow-up results demonstrated excellent safety and efficacy of LuX-Valve Plus in large annulus patients. Despite more severe baseline conditions—including higher TR grades, elevated surgical risk, impaired right ventricular function, enlarged right atrial volume, and greater annular dilation—LuX-Valve Plus achieved significant TR reduction, improved quality of life, and maintained a low rate of composite adverse events.

**Ken-Valve: 1-Year Clinical Follow-Up Results for Large Annulus Patients** The prospective, multicenter, single-arm clinical trial of the transcatheter aortic valve replacement system Ken-Valve assessed its safety and efficacy in symptomatic aortic regurgitation (with or without stenosis) patients at high surgical risk. The study included 142 patients from 15 Chinese centers.

Ken-Valve provides six valve sizes from 23mm to 33mm. In this study, over 45% of patients received valves sized 29mm, 31mm, or 33mm, with an average age of 72 years and a mean STS score of 5.60%.

Large annulus patients face anatomical challenges, leaving few viable treatment options. Despite worse baseline aortic regurgitation grades, wider landing zones, and more severe annular dilation, Ken-Valve demonstrated strong safety and efficacy at the 1-year follow-up, significantly improving regurgitation grades, enhancing quality of life, and maintaining a low composite adverse event rate.

The broad applicability of Ken-Valve in large annulus patients offers an encouraging treatment option for severe aortic regurgitation, potentially fulfilling substantial unmet clinical needs.