Numerous mechanical circulatory support devices are currently utilized for post cardiotomy, bridge to recovery, bridge to transplant and destination therapy. These devices include both pulsatile and continuous flow devices, and there are numerous continuous flow devices under development around the world. Penn State, in cooperation with ABI, Inc., has developed a unique and innovative Tesla type blood pump design that addresses shortcomings encountered in existing continuous flow devices such as thrombosis and hemolysis. The PSU/ABI LVAD system employs a unique passive rotor suspension system with large blood flow channels that do not create hemolytic shear stresses yet provide for adequate surface washing. The latest computational fluid dynamics techniques combined with proven in vitro and in vivo testing, will be combined to develop an improved LVAD system by, 1) scaling a previously ABI developed cardiopulmonary bypass pump while maintaining fluid dynamics similitude, 2) developing a physiologic control system that avoids unphysiologic pressures, 3) in vitro hemolysis and hydraulic testing, 4) integrating existing electronics from the Arrow LionHeart and CorAide systems and 5) evaluation of system performance in vivo. All research and development will be accomplished in compliance with the FDA Quality Systems regulations. This proposal has been carefully revised to address the questions and comments of previous reviewers. It contains a refined design system that is smaller while maintaining system performance.
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