This award is funded under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5). This Small Business Innovation Research (SBIR) Phase I project aims to develop the next generation of vascular embolization coils using proprietary shape memory polymer (SMP) technology. Coils are used to occlude or isolate vessels for treatment of malformations, hemorrhage and tumor isolation. Current metal coils are expensive, cannot effectively occlude large vessels, and exhibit limitations resulting in long procedures. EndoShape's (ESI) SMP technologies promise to significantly reduce device cost, reduce procedure time, achieve large vessel closure, while enabling a broad set of medical procedures. This project leverages previous material research from the University of Colorado, combined with ESI's ongoing development work on device design and SMP manufacturing technology. To optimize design, we focus on: resistance to migration, fatigue, and biocompatibility. By employing finite element analysis, in vitro testing and animal evaluation, we efficiently distill many design and material combinations to the most promising candidates. Phase I work will pursue a sub-set of these goals. The broader impacts of this research are providing physicians with more effective and more cost efficient devices that can be adapted to an expanded patient population and a broader set of medical procedures. A direct benefit of an SMP embolic coil is an expanded indication for use in pediatrics, or neurovascular intervention, wherein current metal coils have limited utility or present compromises (e.g. imaging artifacts) associated with their material. Further clinical advances through integration of tissue engineering or development of patient specific devices can be leveraged from the success of these devices
