In Silico Design and In-Vivo Analysis of the Pediaflow™ Pediatric Ventricular Assist Device

Mechanical circulatory support for the smallest newborn pediatric patients has historically been limited to extracorporeal membrane oxygenation, which can only provide several days to weeks of full cardiac support; far short of the median waiting time for pediatric heart transplantation of nearly three months [1]. Recently, new technologies have been developed, including the PediaFlow pediatric ventricular assist device, to address this need. The PediaFlow device is a magnetically levitated (mag lev), mixed flow turbodynamic blood pump which has been developed in large part in silico using CFD-based inverse design optimization and closed form rotor dynamics models [2, 3]. Each prototype undergoes a series of in vitro and in vivo tests to verify the accuracy of the simulations in predicting performance and biocompatibility. The overall goal is continued refinement and progress towards an implantable pump that produces 0.3 −1.5 L/min for up to 6 months in pediatric heart failure patients from 5 to 15 kg. We describe here the design principles and test procedures for the first three prototypes as well as the predicted performance for a fourth prototype currently being prepared for testing (Figure 1).