SBIR Phase II: Minimally invasive device for restoration of ventricular diastolic recoil without blood contact

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to provide a device-based therapeutic option to heart failure (HF) patients with diastolic dysfunction (insufficient heart relaxation/filling), as current treatments are largely ineffective. Approximately half of people with HF have diastolic dysfunction, equating to an estimated 4 million patients in the US. There are currently no therapies that treat the underlying causes of this disease. Thus, a vast unmet need exists for a solution that can relieve symptoms while correcting and reversing the aberrant heart mechanics that contribute to disease progression. The proposed approach improves native heart function, leading to true recovery from the disease. This technology will provide effective treatment to millions of Americans, improving quality of life, patient outcomes, and saving many lives. This Small Business Innovation Research (SBIR) project advances a device for cardiac care. Specifically, this project will: (1) demonstrate and evaluate device efficacy in increasing heart relaxation in an animal model of chronic diastolic heart disease; (2) determine materials specifications and device design; (3) conduct benchtop fatigue testing and evaluation, including the development of a custom life test apparatus; (4) prepare for design transfer to an appropriate medical device manufacturer; and (5) conduct a pilot GLP safety study in an animal model.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.