title: Bioresorbable vascular scaffolds: Biodegradation, drug delivery and vascular remodeling.
abstract: The metallic stents with durable polymers have been effective in reducing the need for revascularization, but the permanent presence of the metal and polymer have been associated with persistent inflammation, hypersensitivity reactions and incidence of thrombosis. Recent innovations of bioresorbable polymers are in development which could serve as temporary scaffolds that degrade into molecules and eventually resorb overtime, and leave the artery free of any permanent prosthetic constraints. The transient scaffolding has the advantages of restoring blood vessel to natural state, improve vasomotor tone and increase lumen enlargement because of expansive remodeling following completion of polymer resorption. The success of bioresorbable vascular scaffolds will depend on the degradation timeline, such that the elastic recoil of the blood vessel and negative remodeling which could potentially lead to restenosis are prevented. Bioresorbable scaffolds with bulky backbone and thick struts could lead to prolonged biodegradation, alter blood flow dynamics and increase thrombogenicity. The development of bioresorbable scaffolds is challenging because of the complexity of finding an ideal balance of polymer biodegradation and controlled drug release over time, such that the fractional drug released achieves optimal inhibitory concentration until the blood vessel remodels to a stable set point. This review discusses the various types of biodegradable materials, factors affecting biodegradation, drug release kinetics, vascular biocompatibility, adaptive vascular remodeling, and challenges in the development of bioresorbable scaffolds to treat vascular restenosis.
authors.affiliation: Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, United States. Electronic address: belay.tesfamariam@fda.hhs.gov.
authors.forename: Belay
authors.initials: B
authors.lastname: Tesfamariam
mesh_terms: D020341:Absorbable Implants; D016503:Drug Delivery Systems; D006801:Humans; D011108:Polymers; D066253:Vascular Remodeling
chemical_list: D011108:Polymers
keywords: Biodegradable materials; Bioresorbable scaffolds; Endothelial injury; Kinetic drug release; Thrombosis; Vascular remodeling