JENSCARE-B(09877): The 12-month clinical follow-up results of patients with large valve disease who received the LuX-Valve Plus EU TRINITY research will be released at EuroPCR 2026, demonstrating the advantages of the product's large size.

JENSCARE-B(09877) announcement: Recently, the results of the 12-month clinical follow-up of patients with large annular lesions in the global multicenter clinical trial (EU TRINITY) of the LuX-Valve Plus vascular aortic valve intervention replacement system were announced at EuroPCR 2026 (2026 European Cardiovascular Intervention Conference), demonstrating its advantage in large size and expected ability to meet a wide range of unmet clinical needs. LuX-Valve Plus EU TRINITY Study: 12-month clinical follow-up results of patients with large annular lesions - presented by Professor Thomas Modine from the University Hospital of Bordeaux, France. The EU TRINITY Study is a global prospective, multicenter, single-arm clinical trial designed to assess the safety and effectiveness of LuX Valve Plus in patients with severe tricuspid regurgitation and high surgical risk. The study included 161 patients from 20 centers worldwide (full analysis set + learning curve), with 18 centers from France, Germany, Spain, Denmark, and the UK. Patients with severe tricuspid regurgitation often have right heart and tricuspid annular dilatation, which is one of the main reasons for the increased difficulty in tricuspid regurgitation intervention treatment. There are few safe and effective clinical treatment options for patients with large annular lesions, and there are many unmet clinical needs. LuX-Valve Plus has seven sizes of valves ranging from 40mm to 70mm. In this EU TRINITY Study, over 75% of patients used valve sizes of 55mm, 60mm, 65mm, and 70mm. This subset of patients had an average age of 77 years, with an average Tri-Score of 13.6%; 9.7% of patients had severe tricuspid regurgitation, 47.8% had massive tricuspid regurgitation, and 42.5% had torrential tricuspid regurgitation. The 12-month clinical follow-up results showed excellent effectiveness and safety of LuX-Valve Plus in patients with large annular lesions. (1) In terms of improvement in tricuspid regurgitation grade, 97.8% of patients with large annular lesions showed no moderate or severe regurgitation; (2) In terms of improvement in New York Heart Association functional class, 91.6% of patients with large annular lesions had postoperative functional class improvement to I/II; (3) In terms of improvement in quality of life, patients with large annular lesions had an average increase of about 17 points in the Kansas City Cardiomyopathy Questionnaire score; in addition, the average 6-minute walk distance increased by about 43 meters for patients with large annular lesions. Despite the baseline data of patients with large annular lesions showing more severe tricuspid regurgitation grade, high surgical risk, right ventricular function, right atrial volume, degree of tricuspid annular dilatation, and more complex anatomical structures, the 12-month clinical follow-up results of patients with large annular lesions in the EU TRINITY Study showed that LuX-Valve Plus provided sustained, excellent safety and efficacy in patients with large annular lesions. Tricuspid regurgitation grade significantly improved, right heart reconstruction led to continuous improvement in cardiac function, quality of life significantly improved, and a lower rate of composite adverse events was maintained.