Jenscare Scientific Co., Ltd. presented encouraging clinical data for two innovative structural heart devices at EuroPCR 2025 in Paris, demonstrating significant therapeutic potential for high-risk patients with severe valve regurgitation. The company released 30-day follow-up results from the global TRINITY trial of its LuX-Valve Plus transcatheter tricuspid valve replacement (TTVR) system and one-year outcomes from its JensClip transcatheter mitral valve repair (TMVr) system.
TRINITY Trial Demonstrates Strong Early Outcomes for Tricuspid Intervention
The TRINITY trial, a global prospective, multicenter, single-arm clinical study, enrolled 161 patients from 20 centers worldwide to evaluate the safety and efficacy of LuX-Valve Plus in patients with severe tricuspid regurgitation and high surgical risk. The international scope included 18 centers from France, Germany, Spain, Denmark, and the UK.
The patient population presented significant clinical challenges, with an average age of 77 years and an average STS score of 9.92% (14.45% for the Roll-in group). Comorbidities were prevalent, with 72.48% of patients in the FAS group having atrial fibrillation, 32.20% having previous left heart surgery or intervention, and 26.85% having pacemaker or ICD implantation.
The device achieved a 97% success rate with an average operation time of 41.60 minutes, with the shortest procedure completed in just 11 minutes. Over 75% of patients received valve sizes between 55mm and 70mm, demonstrating the system's capability to address large tricuspid valve anatomies.
Safety Profile Shows Low Complication Rates
Safety outcomes at 30 days revealed a composite adverse event rate of 14.8% for the FAS group. Cardiovascular mortality was limited to 1.3%, while stroke incidence and non-selective tricuspid valve surgery or intervention post-procedure each occurred in 0.7% of patients. Major cardiac structural complications affected 2.0% of patients, and severe bleeding occurred in 4.0% of cases.
New pacemaker implantation due to atrioventricular block was required in 8.7% of patients. Notably, no events were recorded for myocardial infarction, new onset renal failure, major access site and vascular complications, or device-related pulmonary embolism.
Efficacy Results Show Significant Functional Improvement
Efficacy outcomes demonstrated substantial improvements in tricuspid regurgitation severity and functional status. In the FAS group, 95.7% of patients achieved no above moderate tricuspid regurgitation, while 84.1% reached postoperative NYHA class I or II. Quality of life measurements showed meaningful improvement, with KCCQ scores increasing by approximately 14 points on average.
Professor Thomas Modine highlighted the device's innovative features, noting its radial-force independent anchoring mechanism specifically designed for tricuspid valve anatomy, low imaging quality demands that reduce procedure time, and large size options enabling wide applicability for large tricuspid valve anatomies.
JensClip Demonstrates Durable One-Year Results
The JensClip study, a prospective, multicenter, single-arm clinical trial, evaluated 114 patients from 18 centers in China with symptomatic degenerative mitral regurgitation at high surgical risk. The patient population had an average age of 71 years with an average STS score of 7.65.
Baseline characteristics revealed significant comorbidity burden, with 63.2% having hypertension, 41.2% having coronary artery disease, 30.7% having atrial fibrillation, and 91.2% presenting with pre-operative NYHA class III or IV symptoms. The device achieved a 97% success rate at 30 days with an average operation time of 67.53 minutes.
One-Year Safety and Efficacy Outcomes
At one-year follow-up, all-cause mortality was 1.8%, with unplanned mitral valve intervention or surgery required in 5.3% of patients and stroke occurring in 1.8%. Other complications including renal failure, myocardial infarction, major bleeding, device releasing or locking failure, and clip-related hemolysis each occurred in 0.9% of patients.
Efficacy results showed sustained improvement, with 96.29% of patients maintaining no above moderate mitral regurgitation and 93.46% achieving postoperative NYHA class I or II. Quality of life measures demonstrated substantial gains, with KCCQ scores increasing by approximately 20 points and six-minute walk distance improving by around 82 meters from baseline.
Professor Xiangbin Pan concluded that JensClip provides easy and reliable operation for severe degenerative mitral regurgitation, with one-year outcomes demonstrating procedural safety and durable mitral regurgitation reduction.
Innovative Device Technologies Address Unmet Clinical Needs
The LuX-Valve Plus system incorporates breakthrough design elements including interventricular septum anchoring and a leakproof self-adaptive braided ring, enabling non-radial anchoring that effectively prevents AV block. The device has received FDA breakthrough device designation and is enrolled in the FDA's Total Product Life Cycle Advisory Program pilot, with over 700 implantations completed worldwide and follow-up extending beyond six years.
JensClip features an innovative self-locking design intended to improve mitral regurgitation while reducing leaflet tension. The system allows flexible shape adjustments to enhance procedural safety and includes a one-piece release mechanism designed to minimize mis-operation risks and reduce device operation time.
Both devices address significant unmet medical needs in structural heart disease, providing treatment options for high-risk patients who may not be candidates for traditional surgical intervention. Further follow-up of the TRINITY trial and U.S. FDA clinical studies for LuX-Valve Plus are ongoing.
