Risk Assessment and Regulatory Exploration of the Lubrication Coating on Intravascular Medical Devices

被引：1

作者：

Xu, Yun ^{[1
]}

Ming, Zhang-Yin ^{[2
,3
]}

机构：

[1] Natl Med Prod Adm, Ctr Med Device Evaluat, Beijing, Peoples R China

[2] Huazhong Univ Sci & Technol, Tongji Med Coll, Wuhan, Peoples R China

[3] Hubei Key Lab Drug Target Res & Pharmacodynam Eval, Wuhan, Peoples R China

来源：

FRONTIERS IN CARDIOVASCULAR MEDICINE | 2022年 / 9卷

关键词：

lubrication coating; intravascular devices; iatrogenic polymer embolism; coating separation; interventional catheter; interventional guidewires; supervision situation; polymer particulates; HYDROPHILIC POLYMER EMBOLISM; IATROGENIC CAUSE; INFLAMMATION; INTRODUCER; ISCHEMIA; SHEATHS;

D O I：

10.3389/fcvm.2022.883406

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Lubricious polymer coatings are increasingly used on intravascular devices to facilitate application processes. Although increasing reports about the detachment and subsequent embolism of polymer particles, this iatrogenic polymer embolism has not been paid enough clinical attention for many years. This article reviews the hazard of coating separation and the difficulty to find it. Furthermore, this proposes the scientific evaluation concept and regulatory exploration to solve the problems.

引用

页数：5

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