Core Insights - The recent clinical trial results for LuX-ValvePlus, JensClip, and Ken-Valve presented at TCT2025 demonstrate significant advancements in the treatment of heart valve diseases, showcasing their safety and efficacy in various patient populations [1][2][3][4] Group 1: LuX-ValvePlus - The TRINITY study's 6-month follow-up results indicate that LuX-ValvePlus exhibits good safety and efficacy, with a stable low incidence of adverse events compared to the 30-day follow-up [2] - Over 75% of enrolled patients in the TRINITY study used larger valve sizes (55mm, 60mm, 65mm, and 70mm), highlighting its broad application, especially for patients with severe tricuspid regurgitation [2] - The FDA IDE-EFS for LuX-ValvePlus has completed all enrollments with a 100% procedural success rate, and a pivotal study is set to commence [2] Group 2: JensClip - JensClip, designed for treating severe mitral regurgitation, shows excellent one-year follow-up results, with an all-cause mortality rate of only 1.8% and minimal device-related complications [3] - 96.3% of patients demonstrated no moderate or severe regurgitation, with significant improvements in quality of life metrics [3] Group 3: Ken-Valve - Ken-Valve, aimed at high-risk surgical patients with severe aortic regurgitation or mixed aortic stenosis, also shows promising one-year follow-up results, with 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 accommodate complex anatomical challenges, addressing the limited treatment options for large annulus patients [4] Group 4: Overall Company and Industry Impact - The comprehensive research outcomes for tricuspid, mitral, and aortic valves have garnered significant attention and praise from global experts at TCT2025 [4] - The company aims to leverage its extensive clinical experience and innovative product designs to advance the global application and commercialization of its product portfolio across various regions [4]
健世科技-B(09877)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