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
Dec 30, 2025

智通财经APP讯,微创心通-B(02160)发布公告,近日,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。一年随访结果显示,手术技术成功率高达97%,所有患者的MR均被完全消除,二尖瓣跨瓣压差从基线时的平均2.5mmHg降至术后的2.1mmHg,心脏血流动力学显着改善。安全性方面,经心尖组一年全因死亡率为17%,经房间隔组仅7%,其中心源性死亡率为0。整个队列中,无中风、新发房颤或二尖瓣再干预等不良事件发生。96%的患者在一年时纽约心脏协会 (NYHA)心功能分级提升至I-II级,生活质量大幅改善。

AltaValveTM已于2024年获得美国食品药物管理局(FDA)授予的两项突破性设备称号,并已根据FDA批准的研究用医疗器材豁免(IDE)在欧洲和美国开展关键临床研究。

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