By Fineline Cube 
Ningbo-based structural heart disease device maker Jenscare Scientific Co., Ltd (HKG: 9877) announced positive 30-day follow-up results from the global TRINITY study of its LuX-Valve Plus transcatheter tricuspid valve replacement system at New York Valves 2025.
Clinical Trial Details
This prospective, multicenter, single-arm clinical trial was conducted across 20 global centers and enrolled 149 high-surgical-risk patients with severe tricuspid regurgitation (TR). Over 75% of patients had large annuli requiring 55-70mm valves.
Key Findings
The study demonstrated a 97% procedural success rate in patients with large annuli, with an average procedure time of 41.6 minutes. Notably, the shortest procedure time was just 11 minutes.
30-Day Follow-Up Results
The 30-day follow-up revealed that 95.7% of patients had no moderate or severe reflux. 84.1% of patients experienced improved New York Heart Association (NYHA) heart function grading to I/II. Additionally, the average Kansas City Cardiomyopathy Questionnaire (KCCQ) quality of life score increased by 15 points. Safety outcomes were also favorable, with a cardiovascular mortality rate of 1.3% within 30 days.
Clinical Significance
Jenscare highlighted that LuX-Valve Plus demonstrated both safety and clinical efficacy in this anatomically challenging cohort of patients with large annuli and advanced disease.
Future Studies
Long-term follow-up and studies with the U.S. Food and Drug Administration (FDA) are ongoing to further evaluate the device’s performance.-Fineline Info & Tech