Overview and focus points of clinical evaluation and review of trans-catheter mitral valve clip system
10.3969/j.issn.1672-8270.2024.08.031
- VernacularTitle:经导管二尖瓣夹系统临床评价审评概述及审评关注点
- Author:
Jing LIU
1
;
Hong LU
;
Yinghui LIU
Author Information
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
- Keywords:
Mitral valve repair;
Percutaneous surgery;
Clinical evaluation;
Edge to edge
- From:
China Medical Equipment
2024;21(8):171-175,186
- CountryChina
- Language:Chinese
-
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.
