Jenscare Scientific Co., Ltd. (Stock Code: 9877) recently announced six-month clinical follow-up data for patients with large annulus in the global multicenter LuX-Valve Plus TRINITY study and one-year clinical application results for Ken-Valve in large annulus patients. Both sets of findings were released at PCR London Valves 2025, highlighting the potential of these devices to meet significant unmet clinical needs.
In the LuX-Valve Plus TRINITY study, 161 patients were enrolled across 20 centers. Over 75% underwent treatment with valve sizes of 55mm to 70mm, indicating enlarged dilatation of the tricuspid annulus. The device success rate reached about 97%, while the average device operation time was approximately 42 minutes. Postoperative follow-up at six months showed notably reduced tricuspid regurgitation (94.4% of patients had no more than moderate residual regurgitation) and over 90% of patients achieved New York Heart Association (NYHA) cardiac function class I/II. The large annulus subgroup recorded similarly favorable outcomes, suggesting effectiveness and safety even in patients with complex anatomical structures.
For the Ken-Valve TAVR system, the prospective, multicenter study enrolled 142 patients across 15 centers in China. More than 45% received valve sizes of 29mm, 31mm, or 33mm. The device success rate was 97.2%, and the average device operation time was approximately nine minutes. One-year follow-up showed all large annulus patients had no more than moderate aortic regurgitation, with 96.7% achieving NYHA class I/II. Quality-of-life assessments also improved markedly, demonstrating the valve’s potential to address severe aortic regurgitation in a broader patient population.
The announcement included a cautionary statement indicating that there is no assurance the company will ultimately develop and market LuX-Valve Plus or commercialize Ken-Valve successfully. Shareholders and potential investors are advised to exercise caution when dealing in the company’s shares.