Chopra Amitabh Madhukumar
Biomed Instrum Technol. 2019;53(6):426-432. doi: 10.2345/0899-8205-53.6.426.
Lubricious polymer coatings are increasingly used on intravascular devices to facilitate easier access and navigation through tortuous blood vessels. Recent reports highlight the separation and downstream embolism of polymer particles affecting the vasculature and various organs. The Food and Drug Administration (FDA) acknowledges polymer coating embolism as an iatrogenic complication of intravascular devices and continues to close gaps in standards related to coating integrity. The Association for the Advancement of Medical Instrumentation established particulate testing as an industry standard for evaluating coating integrity of intravascular devices. The FDA recognizes this standard; however, challenges exist in setting particulate limits that may compromise device function without sufficient clinical data. The microscopic nature of polymer emboli not visible with available imaging modalities has impacted reporting. This has also resulted in a reduced number of manufacturer-driven product development projects related to coating integrity. On the other hand, recent procedural trends have supported the innovation of coated devices with expanded indications, requiring particulate evaluations and release limits. This article proposes a methodology to set particulate limits for intravascular devices given existing clinical, regulatory, and manufacturing challenges. The approach with standardization requirements enables characterization, comparison, and evaluation of lubricious coatings from various manufacturers. It incorporates a step-by-step procedure that adds scrutiny to the application of coatings while ensuring device function is not impacted. Together with particulate assessments, clinicopathologic and animal studies permit an understanding of particulate ranges from commercially available devices and setting of particulate limits for new device evaluations.
润滑性聚合物涂层越来越多地用于血管内装置，以便于在曲折的血管中更轻松地进入和导航。最近的报告强调了聚合物颗粒的分离和下游栓塞会影响脉管系统和各个器官。美国食品药品监督管理局（FDA）承认聚合物涂层栓塞是血管内装置的一种医源性并发症，并继续缩小与涂层完整性相关的标准差距。医疗仪器促进协会将颗粒测试确立为评估血管内装置涂层完整性的行业标准。FDA认可这一标准；然而，在没有足够临床数据的情况下设定可能会损害装置功能的颗粒限度存在挑战。聚合物栓子的微观性质无法通过现有的成像方式看到，这影响了报告。这也导致了制造商驱动的与涂层完整性相关的产品开发项目数量减少。另一方面，最近的手术趋势支持了具有扩大适应症的涂层装置的创新，这需要进行颗粒评估和释放限度设定。本文提出了一种在现有临床、监管和制造挑战的情况下为血管内装置设定颗粒限度的方法。具有标准化要求的方法能够对来自不同制造商的润滑性涂层进行表征、比较和评估。它包含了一个逐步的程序，在确保不影响装置功能的同时，增加了对涂层应用的审查。与颗粒评估一起，临床病理和动物研究有助于了解市售装置的颗粒范围，并为新装置评估设定颗粒限度。
