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BEIJING, June 3, 2025 /PRNewswire/ -- Jenscare Scientific Co., Ltd. ("Jenscare" or the "Company") (HKEX: 9877), an innovative medical device company, recently released 30-day follow-up results of TRINITY Trial of LuX-Valve Plus, a promising self-developed TTVR system, and 1-year outcomes of JensClip, a proprietary TMVr system, at EuroPCR 2025 in Paris, France.
30-Day Follow-up Results of LuX-Valve Plus TRINITY Study
TRINITY is a global prospective, multicenter, single-arm clinical trial, which primarily aims to evaluate the safety and efficacy of LuX-Valve Plus in application on patients with severe tricuspid regurgitation and high surgical risk. The study enrolled 161 patients from 20 centers around the world, among which, 18 centers were from France, Germany, Spain, Denmark, and the UK.
The average age of the patients is about 77 years old with an average STS score of 9.92% (14.45% of Roll-in group). For FAS group, 72.48% of the patients has atrial fibrillation, 32.20% has left heart surgery/intervention, 26.85% has pacemaker/ICD implanted. For Roll-in group, 91.76% of the patients has atrial fibrillation, 41.67% has left heart surgery/intervention, 25.00% has pacemaker/ICD implanted. Patients are combined with multi other comorbidities, which formed a poor baseline and increased the risks of surgical treatment or difficulties of other interventional therapies. Over 75% of enrollments utilized valve sizes between 55mm and 70mm. The results show that the device success rate is about 97%, and the average device operation time is around 41.60 minutes with the shortest time being 11 minutes.
The safety indicators show that the overall CEC-adjudicated composite events rate at 30-day is 14.8% of FAS group and 14.9% with Roll-in group included. For FAS group, cardiovascular mortality is 1.3%, the incidence of strokes and non-selective tricuspid/valve surgery/intervention post procedure are both 0.7%, major cardiac structural complications is 2.0%, severe bleeding (including fatal, life-threatening and extensive bleeding as defined by MVARC) is 4.0%, new pacemaker implantation due to AVB is only 8.7%. No events prevailed in myocardial infarction, new onset renal failure, major access site and vascular complications, and device-related pulmonary embolism. For Roll-in group, both non-selective tricuspid/valve surgery/intervention post procedure and new pacemaker implantation showed one event. And there are no events prevailed in cardiovascular mortality, myocardial infarction, strokes, new onset renal failure, severe bleeding, major cardiac structural complications, and device-related pulmonary embolism.
The efficacy indicators show that the tricuspid regurgitation (TR) grade, NYHA classification, and QoL improved significantly at 30 days. For FAS group, 95.7% of the patients show no above moderate TR. 84.1% of them show postoperative NYHA class I/II. KCCQ score increased by around 14 pts on average. For Roll-in group, 91.7% of the patients show no above moderate TR. 58.3% of them show postoperative NYHA class I/II. KCCQ score increased by around 18 pts on average.
Professor Thomas Modine concluded that LuX-Valve Plus TTVR system is an innovative device indicated for high-surgical risk patients with severe TR and demonstrates several advantages. First, it features radial-force independent anchoring mechanism, which is designed particularly for TV. Second, it indicates low demands on imaging quality, which is expected to significantly reduce device time. Third, it provides large size options, which enables wide applicability on large TV anatomies. The 30-day clinical outcomes of TRINITY trial demonstrate good safety and performances, with improvements in quality of life and low rate of composite adverse events. The wide application on large anatomy patients provides encouraging treatment options for severe TR patients, while current therapies are limited. Further follow-ups of TRINITY trial and the U.S. FDA clinical study on LuX-Valve Plus are underway.
One-Year Follow-Up Results of JensClip
The study of JensClip TMVr system is a prospective, multicenter, single-arm clinical trial, which primarily aims to evaluate the safety and efficacy of JensClip in application on patients with symptomatic degenerative mitral regurgitation (DMR) at high surgical risk. The study enrolled 114 patients from 18 centers in China with an average age of 71 years old.
The average age of the patients is about 71 years old with an average STS score of 7.65. 63.2% of the patients has hypertension history, 41.2% has coronary artery disease, 30.7% has atrial fibrillation, and 91.2% has pre-operative NYHA class III/IV. The results show that the device success rate at 30 days is about 97%, and the average device operation time is around 67.53 minutes.
The safety indicators show that all-cause mortality is 1.8%. The incidence of unplanned mitral valve intervention/surgery is 5.3%, and that of stroke is 1.8%. The incidence of renal failure, myocardium infarction, major bleeding, device releasing/locking failure, and clip related hemolysis are all 0.9%. No events prevailed in SLDA and device related air embolism.
The efficacy indicators show that the mitral regurgitation (MR) grade, NYHA classification, and QoL improved continuously at 1 year. 96.29% of the patients show no above moderate MR. 93.46% of them show postoperative NYHA class I/II. KCCQ score increased by around 20 pts on average. 6MWD increased by around 82m from the baseline.
Professor Xiangbin PAN concluded that JensClip is an innovative device intended for severe DMR, providing easy and reliable operation. The 1-year clinical outcomes demonstrated procedural safety and durable MR reduction.
About LuX-Valve Plus
LuX-Valve Plus, the proprietary TTVR system, is designed for patients with severe tricuspid 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 700 implantation cases have been completed worldwide with the LuX-Valve series products, and the longest follow-up record has been over 6 years.
About JensClip
JensClip, the proprietary TMVr system, features an innovative self-locking design, which is expected to effectively improve mitral regurgitation and reduce leaflet tension. The valve clip allows for flexible shape adjustments, which is expected to enhance procedural safety and improve intraoperative maneuverability. Furthermore, its one-piece release mechanism is designed to minimize potential mis-operation risks associated with staged detachment, effectively reducing device operation time.
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 so on. LuX-Valve series products, the core products, are innovative in the design concepts and treatment solutions for complex tricuspid anatomies. It is expected to become one of the first commercialized tricuspid valve replacement products in the world.
