Development and Pre-Clinical Trial Qualification of a Pediatric Pump-Lung System for Children

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Project Summary The need for reliable and effective cardiopulmonary support devices for young children with lung or heart failure 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. ECMO systems are attractive since they closely simulate physiological gas exchange and circulatory support; but in practice, these systems are limited by their operational complexity, mechanical failure, clots in circuit, and bleeding complications. Systems for pediatric ECMO have not changed substantially in the last decade. Improved outcomes in support of children with either heart or lung failure have been principally due to better selection and management of the patients. A newly designed ECMO system is required for continued reduction in the morbidity and mortality. We propose to contribute a new generation ECMO system based on advanced bioengineering principles focused on an optimized blood flow path and pediatric ICU-enhanced patient mobility with biochemical coatings to reduce platelet adherence. We in partnership with industry partners have developed a series of miniature, integrated pump-oxygenators for both young children and adults. These devices combine uniquely configured hollow fiber membranes with novel blood pump technology, resulting in ultra-compact systems with a low priming volume and improved biocompatibility. The pediatric model, called Pedi Pump-Lung (PediPL), is specifically designed for use for up to 30 days in patients weighing 5-25 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. The objectives of this project are to refine and complete development of the PediPL and associated accessories into an ECMO support system permitting ambulatory respiratory and cardiopulmonary support and to conduct pre-clinical evaluation of readiness for manufacturing of the clinical grade PediPL and pre-clinical testing in compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) in anticipation of anticipation of 510 K clearance and an Investigational Device Exemption (IDE) approval from FDA.