AUTHOR=Xu Yun , Ming Zhang-Yin TITLE=Risk Assessment and Regulatory Exploration of the Lubrication Coating on Intravascular Medical Devices JOURNAL=Frontiers in Cardiovascular Medicine VOLUME=9 YEAR=2022 URL=https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.883406 DOI=10.3389/fcvm.2022.883406 ISSN=2297-055X ABSTRACT=

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.