Non-Blood Contacting Biventricular Cardiac Assist Device That Promotes Heart Restoration.

The proposed research will translate CorInnova's non-blood contacting cardiac assist device technology to human proof of concept. CorInnova's lack of blood contact promises to dramatically reduce the stroke, thrombus, and bleeding complications associated with current cardiac assist devices (blood pumps) primarily used for end-stage heart failure (HF) patients awaiting transplant. Key goals of the research: - Confirm and optimize device design and safety in final animal studies - Adapt design to human sizing and manufacture to GMP standards for first-in-human (FIH) use - Verify device performance in a FIH 6-patient study. Device design will be optimized and tested in one-day efficacy studies in an ovine model of acute HF. 30-day ovine safety studies will evaluate possible side effects including heart abrasions, arrhythmias, wear or fatigue failure, and adhesions preventing device removal. Design work will include materials selection, wear and fatigue testing and FEA analysis. Design and manufacturing to human sizing will follow, including sizing studies. A fully contained device driver will be developed in parallel to provide adequate speed of inflation and deflation, reliable triggering using ECG and internal pressure signals, and adequate user interface. Device safety and hemodynamic performance will then be tested in a FIH 6-patient acute study.