经导管二尖瓣夹系统临床评价审评概述及审评关注点
Overview and focus points of clinical evaluation and review of trans-catheter mitral valve clip system
刘菁 1卢红 2刘英慧2
作者信息
- 1. 国家药品监督管理局医疗器械技术审评检查长三角分中心 上海 201210
- 2. 国家药品监督管理局医疗器械技术审评中心 北京 100081
- 折叠
摘要
经导管二尖瓣夹系统是基于外科二尖瓣缘对缘修复技术,使用可植入二尖瓣夹通过经皮介入手术紧密对接二尖瓣瓣叶,在整个心动周期中使二尖瓣瓣叶紧密对接,达到治疗二尖瓣反流(MR)的效果.目前国内外监管机构已批准多个经导管二尖瓣夹系统评价上市,我国也有十余款经导管二尖瓣夹系统处于上市前临床研究阶段.分析美国食品药品管理局(FDA)对经导管二尖瓣夹系统MitraClip System和Pascal Precision的临床试验和审评关注点,并阐述国产首个上市的二尖瓣夹系统的临床试验,总结该类产品临床评价过程中的审评关注点,以期为该类产品的临床评价和技术审评提供思路.
Abstract
The trans-catheter mitral valve clip system is a method that bases on the surgical mitral valve edge-to-edge repair technique,which uses implanted mitral valve clip to grasp the leaf of mitral valve through percutaneous interventional surgery,which can closely integrate the leaf of mitral valve in the whole cardiac cycle so as to reach the effect of treating mitral regurgitation(MR).At present,multiple transcatheter mitral valve clip systems have been approved by domestic and foreign regulatory agencies.According to incomplete statistics,there are more than ten transcatheter mitral valve clip systems in the pre-market clinical research stage in China.This article analyzed the clinical trials and focus points of Food and Drug Administration(FDA)for the trans-catheter mitral valve clip system(MitraClip System)and Pascal Precision,and introduced the clinical trial of the firstly domestic mitral valve clip system that launched at recently,and summarized the review focus points of this kind of product in the process of clinical evaluation,so as to provide ideas for the clinical evaluation and technical review of this kind of product.
关键词
二尖瓣修复/经皮/临床评价/缘对缘Key words
Mitral valve repair/Percutaneous surgery/Clinical evaluation/Edge to edge引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据