title: Nanophasic biodegradation enhances the durability and biocompatibility of magnesium alloys for the next-generation vascular stents.
abstract: Biodegradable metal alloys emerge as a new class of biomaterials for tissue engineering and medical devices such as cardiovascular stents. Deploying biodegradable materials to fabricate stents not only obviates a second surgical intervention for implant removal but also circumvents the long-term foreign body effect of permanent implants. However, these materials for stents suffer from an un-controlled degradation rate, acute toxic responses, and rapid structural failure presumably due to a non-uniform, fast corrosion process. Here we report that highly uniform, nanophasic degradation is achieved in a new Mg alloy with unique interstitial alloying composition as the nominal formula Mg-2.5Nd-0.2Zn-0.4Zr (wt%, hereafter, denoted as JDBM). This material exhibits highly homogeneous nanophasic biodegradation patterns as compared to other biodegradable metal alloy materials. Consequently it has significantly reduced degradation rate determined by electrochemical characterization. The in vitro cytotoxicity test using human vascular endothelial cells indicates excellent biocompatibility and potentially minimal toxic effect on arterial vessel walls. Finally, we fabricated a cardiovascular stent using JDBM and performed in vivo long-term assessment via implantation of this stent in an animal model. The results confirmed the reduced degradation rate in vivo, excellent tissue compatibility and long-term structural and mechanical durability. Thus, this new Mg-alloy with highly uniform nanophasic biodegradation represents a major breakthrough in the field and a promising material for manufacturing the next generation biodegradable vascular stents.
authors.affiliation: Department of Biomedical Engineering, Yale University, New Haven, CT 06511, USA. rong.fan@yale.edu.
authors.forename: Lin
authors.initials: L
authors.lastname: Mao
authors.forename: Li
authors.initials: L
authors.lastname: Shen
authors.forename: Jialin
authors.initials: J
authors.lastname: Niu
authors.forename: Jian
authors.initials: J
authors.lastname: Zhang
authors.forename: Wenjiang
authors.initials: W
authors.lastname: Ding
authors.forename: Yu
authors.initials: Y
authors.lastname: Wu
authors.forename: Rong
authors.initials: R
authors.lastname: Fan
authors.forename: Guangyin
authors.initials: G
authors.lastname: Yuan
mesh_terms: D000497:Alloys / Q000737:chemistry / Q000378:metabolism* / Q000633:toxicity; D000818:Animals; D001672:Biocompatible Materials / Q000737:chemistry / Q000378:metabolism* / Q000633:toxicity; D002465:Cell Movement / Q000187:drug effects; D002470:Cell Survival / Q000187:drug effects; D004195:Disease Models, Animal; D055664:Electrochemical Techniques; D061307:Human Umbilical Vein Endothelial Cells; D006801:Humans; D008274:Magnesium / Q000737:chemistry*; D049329:Nanostructures / Q000737:chemistry*; D015607:Stents
chemical_list: D000497:Alloys; D001672:Biocompatible Materials; D008274:Magnesium