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: Tags: Review Article Source Type: research