Chopra AM, Rapkiewicz A, Daggubati R, Sequeira A, Hu YC, Bhatt DL, Sharma SK, Cruz JP, Tzafriri AR, Edelman ER. “Analysis: Intravascular Devices with a Higher Risk of Polymer Emboli: The Need for Particulate Generation Testing.”

Summary:
Hydrophilic polymer coatings on intravascular devices lower friction between the device and vasculature, thereby reducing trauma during interventional procedures. Polymer coating embolism – the detachment and downstream embolism of polymer particles – has been reported as an iatrogenic complication of coated interventional devices affecting the vasculature and various organs. This article highlights current procedural trends where the phenomenon of polymer coating embolism may be more prevalent. It describes the mechanisms of polymer separation, reported clinical sequelae, and risk factors for relevant indications. These procedural trends and associated risk factors articulate the need for particulate testing and support the FDA’s draft guidance recommendations for performance testing of applied coatings. Particulate testing is relevant to physicians, regulators, and manufacturers for the purposes of product development and quality improvement of interventional devices.

Biomed Instrum Technol. 2020 Jan./Feb.;54(1):37-43. doi: 10.2345/0899-8205-54.1.37.