Mechanical ventricular assistance has proven to be an effective treatment in the management of cardiogenic shock following open heart surgery and myocardial infarction. Promise for its use as a bridge to cardiac transplantation has been demonstrated. Intra-aortic balloon counterpulsation is the accepted treatment for cardiogenic shock and has proven effective, however, it has limited support capability and a large number of patients with cardiogenic shock are unresponsive to intra-aortic balloon counterpulsation. Pulsatile ventricular assist devices can provide much greater circulatory support than the intra-aortic balloon pump, but present systems are costly, complex, bulky, and require central vascular access via major surgery for implementation. Substantial commercial opportunities for a cost-effective, compact, simple ventricular assist system exist. Nimbus, Inc. has completed initial feasibility studies of an integrated, compact centrifugal pump intended for use as a temporary ventricular assist device. In vitro and in vivo studies have demonstrated acceptable hydraulic, hemolysis and hemodynamic performance. The proposed effort will demonstrate the feasibility of technological innovation which would permit production of a cost-effective centrifugal ventricular assist device. Phase I validates initial studies, refines the existing pump design and completes three seven-day in vivo experiments in collaboration with the Artificial Organs Division of the Cleveland Clinic.
