Biosafety and biodegradation studies of AZ31B magnesium alloy carotid artery stent in vitro and in vivo.

Biosafety of AZ31B magnesium (Mg) alloy and the effect of its degradation products on tissues, organs, and whole systems are highly needed to be evaluated before clinical application. This study serves a wide variety of safety evaluations of biodegradable AZ31B alloy on nerve cells. As a result of this in vitro study, the maximum aluminum (Al) ion and Mg ion concentrations in the medium were estimated to be 22 μmol/L and 2.75 mmol/L, respectively, during degradation. In addition, the corresponding cell mortality was observed to be 36% and lower than 5% according to the resistance curves of the cell to Mg and Al ions. Furthermore, the maximum Al ion and Mg ion concentrations in serum and cerebrospinal fluid were detected to be 26.1 μmol/L and 1.2 mmol/L, respectively, for 5 months implantation. Combining the result of in vivo dialysis with the result of ion tolerance assay experiments, the actual death rate of nerve cells is estimated between 4 and 10% in vivo, which is lower than the result of in vitro cytotoxicity evaluation. Moreover, no psychomotor disability during clinical studies is observed. Consequently, stent made of AZ31B alloy with surface treatment is feasible for carotid artery stenosis, and it is safe in terms of cell viability on the nervous system.