Toward the development of the PediaFlow™ pediatric ventricular assist device: Past, present, future

Abstract

Ventricular Assist Devices (VADs) have revolutionized treatment of adult heart failure with tens of thousands of devices implanted either as a “bridge” to transplant or as a permanent “destination” therapy. There is also a need for VADs for pediatric patients with congenital and/or acquired cardiac disease; yet, the small market potential of pediatrics versus adults has limited commercial interest. Under the support of two completed contract awards from the National Heart, Lung, and Blood Institute and one current award from the Department of Defense Peer Reviewed Medical Research Program, we have designed and validated an implantable, mixed-flow, fully magnetically levitated (maglev), rotodynamic blood pump, the PediaFlow™ pediatric VAD. The clinical design goal for the PediaFlow™ pediatric VAD is to support the failed circulation of infants/neonates and consequently most vulnerable patients for durations consistent with bridge-to-transplant wait list times. Our current fifth generation prototype is the size of an AA cell battery and can achieve flow rates consistent with pediatric circulatory support requirements with minimal cellular damage. We are also currently developing a “smart” closed-loop pump controller which is a quantum improvement over current clinical-use controllers that operate in fixed-output, open-loop mode.