Core Insights - The company has announced promising clinical trial results for its products, LuX-Valve Plus and Ken-Valve, which address significant unmet clinical needs in patients with large annuli [1][2][4] Group 1: LuX-Valve Plus TRINITY Study - The TRINITY study is a global, prospective, multi-center, single-arm clinical trial assessing the safety and efficacy of LuX-Valve Plus in patients with severe tricuspid regurgitation and high surgical risk [2] - The study included 161 patients from 20 centers, primarily in France, Germany, Spain, Denmark, and the UK, with over 75% using valve sizes of 55mm, 60mm, 65mm, and 70mm [2] - The 6-month follow-up results demonstrated excellent efficacy and safety of LuX-Valve Plus in large annulus patients, with significant improvements in tricuspid regurgitation levels and quality of life [3] Group 2: Ken-Valve Study - The Ken-Valve study is a prospective, multi-center, single-arm clinical trial evaluating the safety and efficacy of Ken-Valve in symptomatic aortic regurgitation (or combined stenosis) patients at high surgical risk [4] - The study involved 142 patients from 15 centers in China, with over 45% using valve sizes of 29mm, 31mm, and 33mm [4] - The 1-year follow-up results indicated that Ken-Valve showed excellent safety and efficacy in large annulus patients, with significant improvements in aortic regurgitation levels and quality of life [4]
健世科技-B(09877)：LuX-Valve Plus TRINITY研究大瓣环患者6个月期临床随访结果