This SBIR Phase I project seeks to address the lack of approved device therapies available for the almost 4 million patients in the U.S. who suffer from diastolic heart failure (DHF) - a disease for which the potential market is estimated to be approximately $5B worldwide. In DHF, the chambers of the heart become stiff and cannot relax completely, reducing the amount with which they fill with blood and thus reducing the amount of blood pumped by the heart during each cardiac cycle. The only evidence-based therapy to treat DHF is to manage blood pressure pharmacologically, and treat associated complications. DHF is a major cause of hospital admissions and has poor patient outcomes, without any discernable improvement over the last two decades. Thus, there is a strong need for an effective device solution that can alleviate the symptoms associated with DHF while improving patient outcomes, as well as further fundamental understanding of the key factors and mechanisms that lead to DHF. This project is focused on the development of a non-blood contacting biventricular diastolic recoil device for the treatment of patients with heart failure with preserved ejection fraction (HFpEF), also referred to as diastolic heart failure (DHF). The proposed device will provide a patented minimally invasive, non-blood contacting approach to mitigate the symptoms associated with HFpEF, addressing a large unmet need in a market which currently lacks any approved device therapies. Primary goals of this Phase I project include investigating variations in device design, functionality, and mechanical properties in pilot animal studies in order to optimize augmentation of cardiac function and hemodynamics, as well as the development of an accelerated fatigue test apparatus to test the durability of the device components. The commercialization effort in bringing this novel device to market will address the largely unmet need for the millions of Americans who suffer from DHF by alleviating symptoms, significantly increasing quality of life, and reducing morbidity and mortality. 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.
