Biocompatibility evaluation of NiTi SMA stent via intervenient therapy

1IntrouctlonNi Ti stent are medical devices i mplanted into human body via intervenient therapy,which are wovenout of Ni Ti memory alloy wire.Ni Ti stent for certain purposes are coated with silicon rubber and havelong-termosculation with organs such as esophagus,bile duct,trachea,blood vessel,etc.,which requiresexcellent biocompatibility as an i mportant criterion to ensure their safe and effective clinical application.The International Organization for Standardization has established the …

Biocompatibility evaluation of NiTi SMA stent via intervenient therapy

NiTi shape memory alloy (SMA) stent with film are the long-term implanted medical devices which could be used in human's organ, such as esophagus, bile duct, urethra-prostate and blood vessel, by intervene therapy. It is very important to have a good biocompatibility for implanted device. According to standard ISO 10993, we completed biocompatibility evaluation of NiTi stent that included following tests: cytotoxicity, sensitization, genotoxicity, hemolysis and acute systemic toxicity. The results of tests qualify the NiTi stent, and provide an optimistic conclusion for the eventual use of NiTi stent as implanted medical devices.