Doucet Jensen, Kiri Lauren, O'Connell Kathleen, Kehoe Sharon, Lewandowski Robert J, Liu David M, Abraham Robert J, Boyd Daniel
School of Biomedical Engineering, Dalhousie University, Halifax, NS B3H 4R2, Canada.
Department of Applied Oral Sciences, Faculty of Dentistry, 5981 University Avenue, P.O. BOX 15000, Halifax, NS B3H 4R2, Canada.
J Funct Biomater. 2018 Jan 26;9(1):14. doi: 10.3390/jfb9010014.
Considerable efforts have been placed on the development of degradable microspheres for use in transarterial embolization indications. Using the guidance of the U.S. Food and Drug Administration (FDA) special controls document for the preclinical evaluation of vascular embolization devices, this review consolidates all relevant data pertaining to novel degradable microsphere technologies for bland embolization into a single reference. This review emphasizes intended use, chemical composition, degradative mechanisms, and pre-clinical safety, efficacy, and performance, while summarizing the key advantages and disadvantages for each degradable technology that is currently under development for transarterial embolization. This review is intended to provide an inclusive reference for clinicians that may facilitate an understanding of clinical and technical concepts related to this field of interventional radiology. For materials scientists, this review highlights innovative devices and current evaluation methodologies (i.e., preclinical models), and is designed to be instructive in the development of innovative/new technologies and evaluation methodologies.
人们已付出巨大努力来开发用于经动脉栓塞适应症的可降解微球。本综述以美国食品药品监督管理局(FDA)关于血管栓塞装置临床前评估的特殊控制文件为指导,将所有与用于单纯栓塞的新型可降解微球技术相关的数据整合到一份参考文献中。本综述强调预期用途、化学成分、降解机制以及临床前安全性、有效性和性能,同时总结了目前正在开发用于经动脉栓塞的每种可降解技术的主要优缺点。本综述旨在为临床医生提供一份全面的参考文献,以促进他们对与该介入放射学领域相关的临床和技术概念的理解。对于材料科学家而言,本综述突出了创新装置和当前评估方法(即临床前模型),并旨在对创新/新技术及评估方法的开发具有指导意义。