Jenscare Scientific Co., Ltd. announced that the one-year results of the confirmatory clinical trial of the LuX-Valve transcatheter tricuspid valve replacement system ("LuX-Valve") were recently officially released at the PCR London Valves 2023 by the proponent of the tricuspid risk assessment system TRI-SCORE, Professor Julien Dreyfus from Centre Hospitalier de Saint-Denis (Fa Guo Ba Li Sheng Dan Ni Si Yi Yuan) in Paris, France. The LuX-Valve confirmatory clinical trial is a prospective, multicenter and single-arm study. The confirmatory clinical study of the LuX-ValVE enrolled a total of 126 patients with severe tricuspid regurgitation ("TR") and is designed to evaluate the safety and efficacy of LuX-Valve in patients with severe TR.

The primary endpoint of the clinical trial was cumulative all-cause mortality at one year after surgery. The one-year efficacy results showed: The LuX-Valve significantly reduced TR, improved patients' cardiac functions and enhanced their quality of life. The ultrasonographic data showed that 99.1% of the patients had an improved TR grade, 94.4% of the patients had their TR grade reduced to mild or less, and 75.7% of the patients had recovered to no or trivial TR.

The one-year safety results showed: All-cause mortality, (10.32%), Cardiogenic mortality, (4.76%), Incidence of renal failure, (4.0%), Incidence of hepatic failure, (2.4%), Incidence of grade III atrioventricular block or need for permanent pacemaker implantation, (1.6%), Intraoperative conversion to surgical valve replacement or valvuloplasty, (0.8%), Stroke, (2.4%), INCidence of pulmonary infarction, (0), Valve stent fracture. At 30 days of follow-up, 66.3% of patients' NYHA cardiac functions improved from preoperative grade III/IV to grade I/II; at one year of follow-up, 79.8% of patients improved from preoperative grade III-IV to grade I/II, demonstrating the product's ability to continuously improve patients' cardiac functions. 6MWD (6-minute walking distance) increased from the baseline of 324.3m to 333.6m at 30 days of follow- up, and to 383.2m at one year of follow- up, significantly improving the patients' quality of life.

As of the date of this announcement, nearly 500 implantation cases have been completed worldwide for the transcatheter tricuspID valve replacement system series independently developed by the Company, with the longest follow-up record of more than five years.