Degradation behaviors and in-vivo biocompatibility of a rare earth- and aluminum-free magnesium-based stent

Abstract

Biodegradable stents can provide scaffolding and anti-restenosis benefits in the short term and then gradually disappear over time to free the vessel, among which the Mg-based biodegradable metal stents have been prosperously developed. In the present study, a Mg-8.5Li (wt.%) alloy (RE- and Al-free) with high ductility (> 40%) was processed into mini-tubes, and further fabricated into finished stent through laser cutting and electropolishing. In-vitro degradation test was performed to evaluate the durability of this stent before and after balloon dilation. The influence of plastic deformation and residual stress (derived from the dilation process) on the degradation was checked with the assistance of finite element analysis. In addition, in-vivo degradation behaviors and biocompatibility of the stent were evaluated by performing implantation in iliac artery of minipigs. The balloon dilation process did not lead to deteriorated degradation, and this stent exhibited a decent degradation rate (0.15 mm/y) in vitro, but divergent result (> 0.6 mm/y) was found in vivo. The stent was almost completely degraded in 3 months, revealing an insufficient scaffolding time. Meanwhile, it did not induce possible thrombus, and it was tolerable by surrounding tissues in pigs. Besides, endothelial coverage in 1 month was achieved even under the severe degradation condition. In the end, the feasibility of this stent for treatment of benign vascular stenosis was generally discussed, and perspectives on future improvement of Mg-Li-based stents were proposed.

Keywords: Biocompatibility; Biodegradable stent; Degradation behavior; Iliac artery; Mg-Li alloy.