Polymer coating embolism from intravascular medical devices — a clinical literature review
Over the past three decades, lubricious (hydrophobic and/or hydrophilic) polymer-coated devices have been increasingly adopted by interventional physicians and vascular surgeons to access and treat a wider range of clinical presentations. Recent clinical literature highlights the presence of polymer coating emboli within the anatomy — a result of coating separation from an intravascular device — and associates it with a range of adverse clinical sequelae. The 2015 U.S. Food and Drug Administration safety communication titled “Lubricious Coating Separation from Intravascular Medical Devices” acknowledges these concerns a nd concludes that it will work with stakeholders to develop nonclinical test methodologies, establish performance criteria, and identify gaps in current national and international device standards for coating integrity performance.
Source: Cardiovascular Pathology - Category: Cardiology Authors: Amitabh M. Chopra, Monik Mehta, Jean Bismuth, Maksim Shapiro, Michael C. Fishbein, Alina G. Bridges, Harry V. Vinters Tags: Review Article Source Type: research
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