Jenscare released its multi-product portfolio's, including LuX-Valve Plus TRINITY study, JensClip and Ken-Valve, remarkable clinical outcomes at TCT 2025 in the U.S.

Thu, 30 Oct 2025 09:00:00 +0800

BEIJING, Oct. 30, 2025 /PRNewswire/ -- Jenscare Scientific Co., Ltd. ("Jenscare" or the "Company") (HKEX: 9877), an innovative medical device company, recently released 6-month follow-up results of TRINITY Trial of LuX-Valve Plus, a promising self-developed TTVR system, and 1-year outcomes and challenging cases of JensClip and Ken-Valve, a proprietary TMVr system and TAVR (AR) system respectively, representing the Company's diversified and high-potential multi-product portfolio, at TCT 2025 in the U.S..

6-Month Follow-up Results of LuX-Valve Plus TRINITY Study
-Released by Prof. Thomas Modine, CHU de Bordeaux-Haut-Leveque, France

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 (FAS + Roll-in group) is about 77 years old with an average STS score of 10.24%. 91.93% of the patients has atrial fibrillation, 32.92% has left heart surgery/intervention, 26.71% 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 6-month of FAS + Roll-in group is 19.9%. Cardiovascular mortality is 3.7%, the incidence of strokes is 0.6%, new onset renal failure is 1.2%, non-selective tricuspid valve surgery/intervention post procedure is 2.5%, major cardiac structural complications is 3.1%, severe bleeding (including fatal, life-threatening and extensive bleeding as defined by MVARC) is 5.0%, new pacemaker implantation due to AVB is only 8.7% (no change compared to that at 30 days). No events prevailed in myocardial infarction, major access site and vascular complications, and device-related pulmonary embolism.

The efficacy indicators show that the tricuspid regurgitation (TR) grade, NYHA classification, and QoL improved significantly at 6 months. 94.4% of the patients show no above moderate TR. 90.9% of them show postoperative NYHA class I/II. KCCQ score increased by around 19 pts on average. 6MWD increased by 39 meters 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 has 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 6-month 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 clinical evidence worldwide using LuX-Valve Plus system are underway. Currently, the U.S. FDA IDE-EFS for LuX-Valve Plus has completed full enrollment with excellent safety and efficacy outcomes.

Meanwhile, evidence supporting the efficacy and safety of the transjugular approach for LuX-Valve Plus was also presented. The advantages of the transjugular approach include low incidence of access site bleeding complications, reflecting high safety profile; shorter device operation time, demonstrating good procedural efficiency; and a low screening failure rate due to the anatomical structure of the jugular vein. Current data from the TRAVEL II and TRINITY studies show bleeding complication rates of 0% and 1.8% respectively, representing outstanding clinical outcomes.

One-Year Follow-Up Results of JensClip
-Released by Prof. Vinicius Esteves, University Hospitals in Cleveland, U.S.

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.

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 95%, and the average device operation time is around 67.53 minutes.

The safety indicators show that the all-cause mortality rate 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 Vinicius Esteves concluded that JensClip is an innovative device intended for severe DMR, providing easy and reliable operation with unique designing features like continuous-adjustable locking system and independent grasping technique. The 1-year clinical outcomes demonstrated procedural safety and durable MR reduction.

One-Year Follow-Up Results of Ken-Valve
-Released by Prof. Anson Cheung, St. Paul's Hospital, Canada

The study of Ken-Valve TAVR system is a prospective, multicenter, single-arm clinical trial, which primarily evaluates the safety and efficacy of Ken-Valve in application on patients with symptomatic aortic regurgitation (or combined with aortic stenosis) at high surgical risk. The study enrolled 142 patients from 15 centers in China.

The average age of the patients is about 70 years old with an average STS score of 5.87%. 61.97% of the patients has moderate to severe frailty, 71.83% has hypertension history, 42.96% has coronary artery disease, 48.59% has peripheral vascular disease, 51.41% has prior surgical history, and 99.30% has pre-operative NYHA class III/IV. The results show that the device success rate is about 97%, and the average device operation time is around 8.70 minutes.

The safety indicators show that all-cause mortality is 5.63%. The incidence of severe bleeding is 4.23%, and conversion to surgery is 1.41%. Both the incidence rate of stroke and valve migration is 2.11%. Both the incidence of acute renal dysfunction and needed for cardiopulmonary mechanical assistance is 0.7%. No events prevailed in coronary artery obstruction, thrombosis, and cardiac tamponade.

The efficacy indicators show that the aortic regurgitation (AR) reduction, NYHA classification, and QoL improved continuously at 1 year. 94.7% of the patients show no above moderate paravalvular leakage. 96.2% of them show postoperative NYHA class I/II. EQ-5D score increased by around 19 pts on average. The function and performance of Ken-Valve remain favorable with stable EOA and transvalvular gradient at 1 year.

Professor Anson Cheung concluded that Ken-Valve TAVR system is an innovative device indicated for high-surgical risk patients with severe AR or predominantly regurgitant mixed with aortic valve stenosis with several advantages. Ken-Valve has integrated clamping and radial force anchoring mechanism which can provide reliable anchoring force. It has a leak-proof ring which is expected to minimize PVL post-implantation. It provides large size options which enables wide applicability on large aortic valve anatomies. The deflectable delivery system allows better co-axiality and alignment when treating complex anatomies like horizontal heart. The 1-year clinical outcomes of the Ken-Valve Pivotal Trial demonstrated good safety and performances, with improvements in quality of life, stable EOA and transvalvular gradient, and low rate of composite adverse events. The wide application on large anatomy patients provides encouraging treatment options for severe AR patients while current therapies are limited.

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, close to 1000 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 Ken-Valve

Ken-Valve, the proprietary first-generation TAVR system, is designed for the treatment of patients with severe AR or combined with AS. Its innovative design accommodates a wide range of complex anatomies, significantly improving procedural safety and flexibility while reducing device operation time. It offers six annulus sizes – 23mm, 25mm, 27mm, 29mm, 31mm and 33mm. Its unique innovative design and applicability to complex anatomical challenges, such as large annulus and horizontal heart, can address the treatment needs of patients with large annulus for whom treatment options are relatively limited.

About Jenscare

Jenscare is an innovative medical device company, established in 2011. The Company has achieved a diversified and high-potential product portfolio of interventional treatment solutions for different types of structural heart diseases, including tricuspid valve disease, mitral valve disease, aortic valve disease and so on. The Company is continuing to expand its global business layout, enhancing product influence and clinical application scale, thereby laying a solid foundation for sustained high-speed growth.