Tensile testing as a novel method for quantitatively evaluating bioabsorbable material degradation.

Abstract

Bioabsorbable metallic materials have become a topic of interest in the field of interventional cardiology because of their potential application in stents. A well-defined, quantitative method for evaluating the degradation rate of candidate materials is currently needed in this area. In this study, biodegradation of 0.25-mm iron and magnesium wires was simulated in vitro through immersion in cell-culture medium with and without a fibrin coating (meant to imitate the neointima). The immersed samples were corroded under physiological conditions (37°C, 5% CO(2)). Iron degraded in a highly localized manner, producing voluminous corrosion product while magnesium degraded more uniformly. To estimate the degradation rate in a quantitative manner, both raw and corroded samples underwent tensile testing using a protocol similar to that used on polymeric nanofibers. The effective ultimate tensile stress (tensile stress holding constant cross-sectional area) was determined to be the mechanical metric that exhibited the smallest amount of variability. When the effective tensile stress data were aggregated, a statistically significant downward, linear trend in strength was observed in both materials (Fe and Mg) with and without the fibrin coating. It was also demonstrated that tensile testing is able to distinguish between the higher degradation rate of the bare wires and the lower degradation rate of the fibrin-coated wires with confidence.