WASHINGTON, Oct. 31, 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) on October 29th in Washington, D.C., U.S.. TRAVEL II study results showed that LuX-Valve Plus system is safe and effective in achieving short delivery times, low composite event rates, significant TR reduction and improvement in functional and QoL (quality of life) metrics at 1 year.
TRAVEL II aims to evaluate the long-term safety and efficacy of LuX-Valve Plus in the application on patients with severe tricuspid regurgitation and high surgical risk. The clinical trial enrolled 96 patients from 15 centers in China. The average age of the patients was 71.35 years old with an average STS score of 9.09%. 37.5% of the patients had prior left heart valve surgery/intervention, and 15.63% of them had pacemaker/ICD implanted before. Patients were combined with multi other comorbidities, which formed a poor baseline and increased the risks of surgical treatment or difficulties of other interventional therapies. The results showed that the device success rate was about 97%, and the average device operation time was around 35.56 minutes.
The safety indicators 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%. All-cause mortality was only 4.17%. 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%.
The efficacy indicators showed that the TR grade, NYHA classification, and QoL improved significantly. At 1 year, 95.30% of patients showed no moderate or above tricuspid regurgitation (TR). In terms of NYHA cardiac function improvement, 85% of patients improved from pre-procedure NYHA class III/IV to class I/II. In terms of QoL, patients increased their Kansas City Cardiomyopathy Questionnaire (KCCQ) averaging score by 21 points. The results indicate that the cardiac function and QoL of patients improved continuously.
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.
During the conference period, a case report named "Post-Endocarditis TTVR with the LuX-Valve Plus System" from Clinic Barcelona was shared as well. A 59 year old male patient with previous OH abuse, obesity, type A hepatitis, permanent atrial fibrillation and tricuspid endocarditis complicated with tricuspid regurgitation, right heart failure, pulmonary septic embolism and pulmonary empyema requiring long stay at ICU. Dr. Omar Abdul-Jawad Altisent introduced that the team decided to apply LuX-Valve Plus system after processing the Barcelona Hospital Clinic Algorithm to treat TR due to the high risk for open heart surgery and unfavorable anatomy for repairment (significant dilation of the tricuspid annulus plus a significant gap). The 30-day follow-up showed an improvement in all functional and QoL parameters. In the end, he concluded that this is the first case of a successful percutaneous tricuspid valve replacement in a patient with previous endocarditis, significant aseptic vegetations and advanced right heart failure. The specific design of the LuX-Valve Plus system, including a septal attachment to increase valve stability, various sizes available, along with the flexible properties of the prothesis which permits preservation of the RV function makes this device feasible for most of tricuspid anatomies even at advanced states of the disease or valve destruction.
There were some other interesting sharing of LuX-Valve Plus in many other sessions, such as "Transcatheter tricuspid valve replacement for a patient with torrential tricuspid regurgitation and pacemaker leads", "One-Year Clinical Outcomes of T-TEER versus TTVR among High-Risk Patients with Symptomatic Tricuspid Regurgitation: A Propensity-Score Matched Analysis" etc.. LuX-Valve Plus has gained high attention and recognition after its appearance in New York Valves 2024 earlier this 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.
About LuX-Valve Plus
LuX-Valve Plus, the proprietary TTVR system, is designed for patients with severe tricuspid regurgitation (TR) and high surgical risk. LuX-Valve Plus breaks through multiple technical difficulties in tricuspid valve interventional therapy. With the design of innovative "interventricular septum anchoring" and "leakproof self-adaptive braided ring", which enables non-radial anchoring of the valve implant and tend to effectively prevent AV Block. LuX-Valve series product is designated by the FDA as a breakthrough device, is enrolled in the Total Product Life Cycle Advisory Program (TAP) pilot of the FDA and is selected for the Expert Panel Scientific Advice Pilot by the EMA. 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.
About Jenscare
Jenscare is an innovative medical device company, established in 2011. The Company has achieved a complete product layout of interventional treatment solutions for different types of structural heart diseases, including tricuspid valve disease, mitral valve disease, aortic valve disease and cardioembolic thrombi prevention. LuX-Valve series products, the core products, are innovative in the design concepts and treatment solutions. It is expected to become one of the first commercialized tricuspid valve replacement products in the world.
