SBIR Phase I: Pre-clinical Development of Device to Guide Heart Recovery via Assist and Support

This Small Business Innovation Research (SBIR) Phase I project is focused on a novel therapy for heart failure that employs device mediated intervention to guide cardiac growth, remodeling, and recovery. The CorInnova device is the first to combine active cardiac assist and passive cardiac support. It is non-blood contacting, adjustable post-implantation, and can be delivered via minimally invasive surgical procedures. Hence, CorInnova's technology represents a substantial advancement from both, existing cardiac assist and existing cardiac support technologies. While the device has shown potential in limited short-term animal studies, the full capabilities and limitations of the design are as yet unknown. The research plan is aimed at determining these capabilities and limitations. The broader impacts of this research are important in the treatment of Congestive Heart Failure (CHF). CHF is a debilitating condition that currently afflicts nearly 5 million Americans. Treatment costs are estimated to be in excess of $50 billion per year. For the 300,000 Americans in ""end-stage heart failure"", transplant is the preferred treatment option. However, the lack of donor hearts renders this treatment option ""epidemiologically trivial"". For most of these patients, the potential for cardiac rehabilitation is neglected. Thus, the proposed technology represents a shift in the treatment paradigm - an intervention conceived to stimulate restorative growth and remodeling processes - essentially providing rehabilitative physical therapy for the heart muscle. The versatility of the device empowers the cardiologist, providing the means for tactical intervention via adjustments to the passive support component and application of active cardiac assist. This award is funded under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5).