Abstract
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.
Highlights
Over the past decade, there has been growing interest in the development of degradable microspheres for transarterial embolization (TAE) procedures; especially for applications in trauma, gastrointestinal bleeding, and for the treatment of uterine leiomyoma
Based on the special controls described by Food and Drug Administration (FDA), as they relate to degradable microspheres for TAE applications, this paper intends to consolidate the highest levels of preclinical evidence relating to the safety, efficacy, and performance of new technologies which are under development as degradable microspheres; those that are in development for bland embolization procedures
While this paper examined many morphologies, the current review focuses solely on data relating to the chitosan microspheres (75% deacetylated)
Summary
There has been growing interest in the development of degradable microspheres for transarterial embolization (TAE) procedures; especially for applications in trauma, gastrointestinal bleeding, and for the treatment of uterine leiomyoma. Efficacy, and performance of permanent embolic agents are well established in the clinical literature, degradable microspheres may present new safety concerns. Based on the special controls described by FDA, as they relate to degradable microspheres for TAE applications, this paper intends to consolidate the highest levels of preclinical evidence relating to the safety, efficacy, and performance of new technologies which are under development as degradable microspheres; those that are in development for bland embolization procedures. This paper is structured to cross-reference microsphere composition(s) with the special controls provided by the FDA This format was deliberately chosen to provide a robust framework for discussing the current state of the art technologies with respect to potential risks that may need to be considered as part of a design control process for the development of new degradable microsphere technologies. A review of the preclinical models utilized by the identified papers will be provided to further highlight the current understanding of the safety, efficacy, and performance of degradable microspheres
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