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国产冠状动脉支架历史发展和技术进展
引用本文:商惠,温焘源.国产冠状动脉支架历史发展和技术进展[J].中国医疗器械信息,2020(1):10-13,155.
作者姓名:商惠  温焘源
作者单位:国家药品监督管理局医疗器械技术审评中心;先健科技(深圳)有限公司;元心科技(深圳)有限公司
摘    要:冠脉支架植入术是治疗冠状动脉粥样硬化性心脏病的主流手段之一。国产冠脉支架起步于20世纪末,在过去的19年间,我国的冠脉支架技术发展迅速,从最初的裸支架研发晚于发达国家十几年,到现在完全可降解支架技术已达到国际领先水平。文章聚焦国产冠脉支架发展历程,以不同支架类型的首款产品上市时间为起点,从国产冠脉支架的3个阶段发展阶段--BMS阶段、DES阶段及BRS阶段,简要介绍国产冠脉支架的发展历史。同时,通过对冠脉支架系统的支架平台、药物涂层和输送系统的技术发展历史的综述,简要说明国产冠脉支架系统的技术发展路线以及未来趋势。

关 键 词:冠状动脉粥样硬化性心脏病  冠脉支架  生物可吸收支架  药物洗脱支架

Historical Development and Technological Progress of Domestic Coronary Stent
SHANG Hui,WEN Tao-yuan.Historical Development and Technological Progress of Domestic Coronary Stent[J].China Medical Devices Information,2020(1):10-13,155.
Authors:SHANG Hui  WEN Tao-yuan
Institution:(Center for Medical Device Evaluation,NMPA,Beijing 100089;Lifetech Scientific(Shenzhen)Co.,Ltd.,Guangdong Shenzhen 518063;Biotyx Medical(Shenzhen)Co.,Ltd.,Guangdong Shenzhen 518110)
Abstract:Coronary stent implantation is one of the mainstream methods for the treatment of coronary atherosclerotic heart disease. Domestic coronary stent started in the late 20th century. In the past 19 years, Chinese coronary stent technology has developed rapidly. The initial development of Bare Metal Stent was more than ten years later than in developed countries, and now the Bioresorbable vascular scaffold has reached the international leading level. This article focuses on the development history of domestic coronary stent, dividing it into three development stages-BMS stage, DES stage and BRS stage, which based on the launch of the fist medical device of different stent types. Development history. Meanwhile, the technology development history and future trends of domestic coronary stent systems are briefly introduced through a review of the technological development of the stent platform, drug coating and delivery system of the coronary stent.
Keywords:coronary atherosclerotic heart disease  coronary stent  bioresorbable stent  drug-eluting stent
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