摘要
文章对血管内应用的压力聚焦型、约束型、药物涂层等特殊球囊的结构特点与临床应用进行了梳理,结合结构特点和风险点分析了各类球囊的性能研究关注点,以期为该类产品的研发、注册提供参考。
The structural characteristics and clinical application of specialty balloon were summarized in this paper.According to structural characteristics and risk,performance study concerns were analyzed to provide reference for the development and registration application of such products.
作者
张向梅
李彦弛
陈易北
董珊
ZHANG Xiang-mei;LI Yan-chi;CHEN Yi-bei;DONG Shan(GBA Center for Medical Device Evaluation and Inspection.NMPA,Guangdong Shenzhen 518045)
出处
《中国医疗器械信息》
2024年第21期1-4,共4页
China Medical Device Information
关键词
特殊球囊
压力聚焦型球囊
约束型球囊
药物涂层球囊
性能研究
specialty balloon
focused force balloon
chocolate balloon
drug-coated balloon
performance study
