Jenscare Announces Positive 30-Day Results for LuX-Valve Plus in TRINITY Study

Jenscare Announces Positive 30-Day Results for LuX-Valve Plus in TRINITY Study

Ningbo-based structural heart disease device manufacturer Jenscare Scientific Co., Ltd (HKG: 9877) has announced the 30-day clinical follow-up results from the global multicenter TRINITY study of its LuX-Valve Plus transcatheter tricuspid valve replacement (TTVR) system. Additionally, the company revealed the one-year follow-up results of its JensClip transcatheter mitral valve repair (TMVr) system.

TRINITY Study Results
The TRINITY study is a global prospective, multicenter, single-arm clinical trial evaluating the safety and efficacy of LuX-Valve Plus in patients with severe tricuspid regurgitation at high surgical risk. Enrolling 161 patients across 20 international centers, preliminary results showed a device success rate of approximately 97%. At 30-day follow-up, 95.7% of patients demonstrated no moderate or greater tricuspid regurgitation, 84.1% achieved NYHA Class I/II cardiac function, and the average Kansas City Cardiomyopathy Questionnaire (KCCQ) score improved by approximately 14 points, with low rates of safety events.

JensClip Trial Results
The JensClip prospective multicenter single-arm clinical trial assessed the safety and efficacy of the device in symptomatic degenerative mitral regurgitation (DMR) patients at high surgical risk. Enrolling 114 patients across 18 Chinese centers, results indicated a 95% procedural success rate. One-year follow-up revealed that 96.3% of patients maintained no moderate or greater mitral regurgitation, 93.5% achieved NYHA Class I/II cardiac function, and average KCCQ scores improved by about 20 points, with minimal device-related complications and manageable adverse reactions.-Fineline Info & Tech