国内外植入式心室辅助装置研发与应用进展  

Progress of development and application of implantable VAD of domestic and overseas

作　　者：严舒[1] 陈娟[1] 卢岩 欧阳昭连[1] YAN Shu;CHEN Juan;LU Yan(Institute of Medical Information,Chinese Academy of Medical Sciences,Beijing 100020,China;不详)

机构地区：[1]中国医学科学院医学信息研究所,北京100005

出　　处：《中国医学装备》2022年第1期21-26,共6页China Medical Equipment

基　　金：国家自然科学基金(L1924064)“面向2035的我国再生医学创新与产业发展战略研究”;中国医学科学院医学与健康科技创新工程(2021-I2M-1-056)“医学知识管理与智能化知识服务关键技术研究”。

摘　　要：植入式心室辅助装置(VAD)是用于治疗终末期心力衰竭患者的高端医疗器械,经过50余年的发展,已在全球多个国家获批上市使用,美国、日本、欧盟等国家的上市时间早于我国。VAD产品已经过多次改进迭代,典型类型包括气动式搏动血流、机械轴承连续血流、磁或液悬浮式连续血流,代表性产品来自美国雅培和美敦力及德国BerlinHeart等公司。VAD产品出现的患者不良事件主要包括失血、死亡、血栓、感染等,多个产品出现过召回情况。我国已有1种植入式VAD上市,有多个产品处于研发或审批阶段,此类器械在我国的良性发展需要政府、医疗机构和企业的共同努力。Implantable ventricular assist device(VAD)is a high-end medical device which was used to treat patients with end-stage heart failure.After more than 50 years of development,it has been approved for use in many countries around the world.The times that the product was launched in the United States,Japan and European countries were earlier than China.The VAD products have undergone many improvements and iterations,and typical types of them include pneumatic pulsatile bloodstream,axial continuous bloodstream,and magnetism or liquid suspension continuous bloodstream,and the representative products made from Abbott(US),Medtronic(US)and Berlin Heart(Germany),etc.The adverse events of VAD products mainly include blood loss,death,thrombosis,infection and so on for patients.And recalls once occurred in some products.Only one implantable VAD product is approved to be used in China,and others are under development or reviewing.The well development of this device need the mutual endeavors of government,medical institutions and enterprises in China.

关 键 词：植入式 心室辅助装置(VAD) 产品研发 临床应用 医疗器械监管 

分 类 号：R318.03[医药卫生—生物医学工程]