Effect of Vaporized Hydrogen Peroxide and Nitrogen Dioxide Sterilization on Nitinol.

Nitinol is used as the structural framework in numerous types of medical devices (e.g., guidewires, transcatheters, stents).

A novel accelerated in vitro release method for biodegradable coating of drug eluting stents: Insight to the drug release mechanisms.

The major objective of the present study was to develop an accelerated in vitro release method for everolimus/poly(lactic-co-glycolic acid) (PLGA) biodegradable DES that reflects and discriminates between many different sources of variations in the manufacturing process by introducing organic solvents in the release medium. To get further insight into the underlying drug release mechanisms, alongside release studies, the surface changes of the coated stents and the molecular weight changes of the polymer upon immersion in the selected release media were examined by scanning electron microscopy and size exclusion chromatography. The incorporation of acetonitrile in the release medium resulted in an increase in the drug release rate due to an increment in total porosity of the matrices.