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WASHINGTON, Nov. 1, 2024 /PRNewswire/ -- Jenscare Scientific Co., Ltd. ("Jenscare" or the "Company") (HKEX: 9877), an innovative medical device company dedicated to interventional treatment for structural heart diseases with TTVR breakthroughs, has just released the 1-year outcome of LuX-Valve Plus TRAVEL II study at 2024 Transcatheter Cardiovascular Therapeutics Conference (TCT 2024) by on October 29th in Washington, D.C., U.S..
TRAVEL II study aims to evaluate the long-term safety and efficacy of LuX-Valve Plus in the application on patients with severe tricuspid regurgitation (TR) and high surgical risk. The clinical trial enrolled 96 patients from 15 centers in China. The results showed that the device success rate was about 97%, and the average device operation time was around 35.56 minutes.
Safety results showed that the incidence of composite events remained low at 12.50%.
- Incidence of myocardial infarction, acute liver failure, cardiovascular injury requiring surgical intervention, life-threatening hemorrhage were all 0.00%.
- Incidence of acute renal failure, severe paravalvular leakage, and conversion to surgical tricuspid valve replacement or tricuspid valvuloplasty were 1.04%, 2.08%, and 3.13% respectively.
- Incidence of new onset degree III AVB requiring permanent pacemaker implantation was only 2.08%.
- All-cause mortality was only 4.17%.
Efficacy results showed that TR grade, NYHA classification, and QoL improved significantly and continuously. At 1 year,
- 95.30% of patients showed no moderate or above TR.
- 85% of patients improved from pre-procedure NYHA class III/IV to class I/II.
- Patients increased their Kansas City Cardiomyopathy Questionnaire (KCCQ) averaging score by 21 points.
Professor Juan F. Granada concluded that LuX-Valve Plus system is a versatile TTVR device that does not depend on radial force for anchoring. Its innovative design (ventricular septal anchor & leaflet-grasping clips) provides optional mechanisms for anchoring and stability. The multicenter, TRAVEL II study showed that LuX-Valve Plus system is safe and effective in achieving short delivery times, low 1-year composite event rates, significant TR reduction and improvement in functional and QoL metrics at 1 year.
Additional studies in Europe and the U.S. using the LuX-Valve Plus system are underway, and more clinical results are expected to be released in the future. The Company is continuously advancing the global application of LuX-Valve series system to help more TR patients. As of the latest update, over 600 implantation cases have been completed worldwide with the LuX-Valve series products, and the longest follow-up record has been over 6 years.
