The need for reliable mechanical circulatory support devices for young children with advanced congenital or acquired heart disease is well established. For those pediatric patients who become refractory to conventional therapies, aggressive mechanical circulatory intervention through extracorporeal membrane oxygenation (ECMO) or ventricular assist devices (VADs), may improve the likelihood of survival. However, cardiopulmonary or cardiac support systems specifically designed for infants and children are presently lacking. According to the Extracorporeal Life Support Registry, the number of neonatal (age 0-30 days) and pediatric (30 day-16 years) patients placed on ECMO for cardiac support has been increasing. ECMO systems are effective since they closely simulate physiological gas exchange;but in practice, these systems are limited by their operational complexity, mechanical failure, clots in circuit, and bleeding complications. To address these problems associated with cardiopulmonary support for infants and children, the Artificial Organs Laboratory at the University of Maryland, Baltimore (UMB), in partnership with Levitronix LLC, has developed a series of miniature integrated Maglev pump-oxygenators for both young children and adults. These devices combine uniquely configured hollow fiber membranes with the Levitronix Maglev bearingless pump/motor technology, which are ultracompact, and possess a low priming volume and hemolysis risk. The pediatric model, called Pedi PumpLung (PediPL), was specifically designed for use for up to 30 days in patients weighing 3-25 kg who 1) are not sufficiently stable to be weaned from cardiopulmonary bypass after surgery;2) have severe primary respiratory failure or secondary failure associated with cardiac disease;and 3) experience profound cardiogenic shock and require urgent support.
