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Jenscare released 30-day follow-up results of LuX-Valve Plus TRINITY study and 1-year follow-up results of JensClip TMVr at EuroPCR 2025
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.
About this update from Jenscare Scientific Co. Ltd. Class H
[{"type":"text","content":"BEIJING, June 2, 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.","length":382,"tagName":"p"},{"type":"text","content":"30-Day Follow-up Results of LuX-Valve Plus TRINITY Study","length":56,"tagName":"p"},{"type":"text","content":"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.","length":379,"tagName":"p"},{"type":"text","content":"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.","length":816,"tagName":"p"},{"type":"text","content":"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%...