Jenscare Scientific Co., Ltd. announced that recently, the results of six-month clinical follow-up of multicenter clinical trial of LuX-Valve Plus transvascular tricuspid valve replacement system ("TRAVEL II") were officially published at New York Valves 2024 and the 18th Oriental Congress of Cardiology together with the World Congress of Cardiology. TRAVEL II is a prospective, multicenter and single-arm clinical trial, which primarily evaluates the long-term safety and efficacy of LuX-Valve plus in the application on patients with severe tricuspid regurgitation. The TRAVEL II clinical trial enrolled a total of 96 patients from 15 centers in China.

The results of this clinical study showed: (1) The device success rate was about 97%; and (2) The average device operation time was 35.56+-20.82 minutes. The efficacy results showed: (1) All patients had an improved tricuspid regurgification grade, 30-day data showed that 100% of patients had no moderate or above tricuspid regurgication (TR), and six-month data showed that 97.62% of patients had no moderate and above TR; and (2) In terms of New York Heart Association cardiac function improvement, 30-day data demonstrated that 80.43% of patients improved from pre-procedure class III/IV to class I/II, and six-month data demonstrated that 91.86% of patients improved from pre theprocedure class III/IV to class I/II; and (3) In terms of quality of life, 30-day data demonstrated the patients improved their Kansas City Cardiomyopathy Questionnaire scores, on average, by 15 points, and six-month data demonstrated that patients improved their Kansas City Cardiomyopathy Questionnaire scores, on average, by 20 points.