无源经静脉电极导线拔除装置审评浅析  

Non-Active Transvenous Lead Extraction Devices: An Overview of Regulatory Review

作　　者：许耘 程茂波 XU Yun;CHENG Mao-bo(Center for Medical Device Evaluation.NMPA,Beijing 100076)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京100076

出　　处：《中国医疗器械信息》2024年第19期18-20,共3页China Medical Device Information

摘　　要：随着我国心律植入装置应用数量不断增加,出现导线感染、断裂等相关问题需要拔除电极导线的病例也日趋增多。电极导线与心肌组织或静脉系统粘连增加了电极导线拔除技术的难度。文章对锁定导丝、机械扩张鞘和圈套器等经静脉电极导线拔除的三种无源医疗器械进行概述,并对审评关注点及风险点进行浅析。As the use of cardiac rhythm management devices continues to rise in China,the number of cases requiring lead extraction due to complications such as lead infection,lead fracture,and vascular occlusion is also increasing.The adhesion of the lead to myocardial tissue or the venous system complicates the lead extraction procedure.This article provides an overview of three passive medical devices used for transvenous lead extraction:the locking stylet,mechanical dilation sheath,and snare device.It also discusses key considerations and risks associated with their regulatory review.

关 键 词：心律植入装置 电极导线拔除技术 锁定导丝 机械扩张鞘鞘 圈套器 

分 类 号：TH778[机械工程—仪器科学与技术]