Genotoxic and Biological Evaluation of a Nano Silica Cross Linked Composite Specifically Used for Intra-Vas Device

The Context: Aims: To evaluate the biocompatibility and in vitro genotoxicity of a non-copper nano silica polymer modified composite for filtering-type intra-vas devices. Settings and Design: Academic research laboratory, Huazhong University of Science and Technology. Prospective experimental study. Methods and Material: Non-copper nano silica polymer modified composite rods were implanted into the back muscle of rabbits for biocompatibility evaluation. Comet assay was applied to the determination of DNA damage, while, Mutagenic activity was tested by means of Ames test using Salmonella typhimurium TA98 and TA 100 tester strains with and without metabolic activation. Statistical analysis used: qualitative and quantitative data were tested using the Chi-square test and Student’s test. Results: Only mild inflammatory reaction was observed in the surrounding tissues of the implanted nano-silica modified polymer composite in the early implantation stage, which was similar to that of the sham-operated group. The inflammatory reaction was completely disappeared after 12 weeks. No significant DNA damage (P > 0.05) were tested on the nano-silica modified polymer composite in Comet assay. In Ames test, the extracts from non-copper composite did not exert mutagenic effect on the bacterial. Conclusions: The non-copper nano silica modified composite did not exhibit in vitro genotoxicity and obvious inflammation in tissue, it would be a safe biomaterial for further clinical trial.