This fast track SBIR application proposes the refinement and preclinical testing of a coating designed to inhibit restenosis and thrombosis in intravascular stents. The research plan will build on encouraging results from pilot animal studies with coated prototypes. During Phase I, the coating process will be optimized by thoroughly analyzing system variables and verifying coating properties in each step of the coating application. Preliminary biocompatibility testing will be conducted, to identify local effects of the coating on blood and tissue. Upon meeting defined process requirements and biocompatibility requirements, the project will move to Phase II, where the coating process will be implemented in an automated, controlled application apparatus. The coated stents will undergo extensive durability testing. Animal studies are planned that will investigate the activity of the stent in an isolated vessel model. Finally, the stents will be evaluated in a 28-day porcine implant model. The coating is designed as a stand-alone solution to improve stent performance; however, the coating can be combined readily with other coatings or drug-release agents. ? ? ?
