Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems: Particle-Free Loop Capture Method and SEM Analysis

Drug-Eluting Stents (DES) have greatly impacted treatment methods for cardiovascular disease over the past ten years. Patients receiving DES treatments have a significantly reduced risk of in-stent restenosis, but other risks, such as particulate matter generation, have caused concern in recent years. Particulate matter can be generated by the manufacturing process or from the breakdown of any coating (e.g., hydrophilic coating) or from the stent platform, stent delivery system, or product packaging. If particles are introduced in the bloodstream during stent delivery or deployment, they may present an embolic risk to the patient.