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AltaValveTM经导管二尖瓣置换(TMVR)医疗器械
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微创心通-B股东将股票存入云锋证券 存仓市值6.51亿港元
Zhi Tong Cai Jing· 2026-01-22 00:31
香港联交所最新资料显示,1月21日,微创心通-B(02160)股东将股票存入云锋证券,存仓市值6.51亿港 元,占比9.56%。 微创心通公告,由集团联营公司4C Medical Technologies, Inc.(4C Medical)自主研发的AltaValveTM经导 管二尖瓣置换(TMVR)医疗器械(AltaValveTM)的早期可行性研究一年随访结果正式公布。本次研究覆盖 欧洲、美国、日本多中心,纳入患者30名,均为手术高风险、伴有症状性重度二尖瓣反流(MR)的患 者,其中13名患者采用经心尖入路, 17名采用经房间隔入路。 ...
微创心通-B(02160)股东将股票存入云锋证券 存仓市值6.51亿港元
智通财经网· 2026-01-22 00:24
微创心通公告,由集团联营公司4C Medical Technologies, Inc.(4C Medical)自主研发的AltaValveTM经导 管二尖瓣置换(TMVR)医疗器械(AltaValveTM)的早期可行性研究一年随访结果正式公布。本次研究覆盖 欧洲、美国、日本多中心,纳入患者30名,均为手术高风险、伴有症状性重度二尖瓣反流(MR)的患 者,其中13名患者采用经心尖入路, 17名采用经房间隔入路。 智通财经APP获悉,香港联交所最新资料显示,1月21日,微创心通-B(02160)股东将股票存入云锋证 券,存仓市值6.51亿港元,占比9.56%。 ...
微创心通-B(02160):AltaValveTM早期可行性研究一年随访结果正式公布
智通财经网· 2025-12-30 14:56
Core Insights - The early feasibility study results for the AltaValveTM transcatheter mitral valve replacement (TMVR) device developed by 4C Medical Technologies, Inc. have been published, showing promising outcomes in high-risk patients with symptomatic severe mitral regurgitation (MR) [1][2] Group 1: Study Results - The study included 30 patients across Europe, the United States, and Japan, all of whom were at high surgical risk and had symptomatic severe MR [1] - The technical success rate of the procedure was reported at 97%, with complete elimination of MR in all patients [1] - The mean transvalvular pressure gradient decreased from 2.5 mmHg at baseline to 2.1 mmHg post-procedure, indicating significant improvement in cardiac hemodynamics [1] Group 2: Safety and Outcomes - The one-year all-cause mortality rate was 17% for the transapical group and only 7% for the transseptal group, with no cases of cardiac-related mortality [1] - There were no adverse events such as stroke, new-onset atrial fibrillation, or re-intervention on the mitral valve reported in the entire cohort [1] - 96% of patients improved to NYHA functional class I-II at one year, reflecting a substantial enhancement in quality of life [1] Group 3: Regulatory Status - AltaValveTM has received two breakthrough device designations from the FDA in 2024 and is currently undergoing pivotal clinical studies in Europe and the United States under an FDA-approved Investigational Device Exemption (IDE) [2]