经导管心血管治疗
Search documents
健世科技-B多产品组合LuX-Valve Plus TRINITY研 究、JensClip及 Ken-Valve临床效果于美国TCT 2025发布
Zhi Tong Cai Jing· 2025-10-29 12:10
Core Insights - The recent clinical trial results for LuX-ValvePlus, JensClip, and Ken-Valve presented at TCT2025 highlight significant advancements in the treatment of heart valve diseases, showcasing their safety, efficacy, and innovative designs [1][2][3][4] Group 1: LuX-ValvePlus - The TRINITY study demonstrated LuX-ValvePlus's excellent safety and efficacy, with a stable low incidence of adverse events and improved patient quality of life over six months [2] - Over 75% of patients in the TRINITY study used larger valve sizes (55mm to 70mm), indicating its broad application, especially for patients with severe tricuspid regurgitation [2] - The device has achieved a 100% procedural success rate in the FDA IDE-EFS study, with pivotal clinical research set to commence soon [2] Group 2: JensClip - JensClip, designed for severe mitral regurgitation, showed a one-year follow-up result with an all-cause mortality rate of only 1.8% and minimal device-related complications [3] - 96.3% of patients exhibited no moderate or severe regurgitation, with significant improvements in various quality of life metrics [3] Group 3: Ken-Valve - Ken-Valve, aimed at high-risk surgical patients with severe aortic regurgitation, demonstrated excellent one-year follow-up results, maintaining stable effective orifice area and low rates of adverse events [4] - The device is available in multiple sizes (23mm to 33mm) and is designed to address complex anatomical challenges, fulfilling the needs of patients with limited treatment options [4] Group 4: Overall Company Positioning - The comprehensive research outcomes across tricuspid, mitral, and aortic valves garnered significant attention and praise from global experts at TCT2025 [4] - The company plans to leverage its extensive clinical experience and innovative product designs to advance the global application and commercialization of its product portfolio [4]