Core Viewpoint - The recent clinical trial results for LuX-Valve Plus and Ken-Valve demonstrate significant safety and efficacy in treating patients with large annuli, addressing a substantial unmet clinical need in severe tricuspid regurgitation and aortic regurgitation patients. 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, involving 161 patients across 20 centers [1] - Over 75% of patients in the TRINITY study used valve sizes of 55mm, 60mm, 65mm, and 70mm, with an average age of 77 years and a Tri-Score of 13.5% [2] - The 6-month follow-up results indicate excellent efficacy and safety of LuX-Valve Plus in large annuli 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, including 142 patients from 15 centers in China [4] - More than 45% of patients used valve sizes of 29mm, 31mm, and 33mm, with an average age of 72 years and an average STS score of 5.60% [4] - The 1-year follow-up results show that Ken-Valve maintains excellent safety and efficacy in large annuli patients, with significant improvements in aortic regurgitation levels and quality of life, addressing a considerable unmet clinical need [4]
健世科技-B：LuX-Valve Plus TRINITY研究大瓣环患者6个月期临床随访结果