Sophisticated ventricular assist devices (VADs) are now routinely used for bridge to recovery, or bridge to transplant in heart failure patients. However, the success of the VADs'applications in adults has not been translated into that in pediatric application, due to the delays in the miniaturization process of these devices. To date, the need of VADs for infant and child with congenital or acquired cardiovascular disease has largely been unmet. Hundreds of infants and children die each year in the United States while waiting for a donor heart. The goal of this """"""""Fast Track"""""""" SBIR application is to develop long-term implantable miniature VADs for infant and child, built upon the success of the current CircuLite Synergy device. The Synergy device is a unique proprietary and patented miniature VAD. Through a decade of development, it has been refined to be the smallest implantable blood pump, only of the size of an """"""""AA"""""""" battery. The device is currently undergoing the CE Mark Trial in Europe and pending USFDA IDE submission. The goal of the Phase I project is to demonstrate the feasibility of using the current CircuLite micro-pump (1.5-3 L/min flow) for child (5-35 kg) by modifying the inlet housing of the device for left ventricular apical insertion, while the Phase II project is to demonstrate the feasibility of further modifying the micro-pump (redesigning the impeller or reducing the pump size) to achieve a reduced flow of 0.3-1.5 L/min for use in an infant (<5 kg). The milestone of the Phase I project will be the delivery of a child VAD that has undergone short-term animal studies. In Phase II, we will further test the child VAD in long-term animal studies and freeze its design for future preclinical GLP studies. Meanwhile, we will develop the infant VAD and complete its short-term animal studies.
To date, the need of long-term circulatory support for infant and child with congenital and acquired cardiovascular disease has largely been unmet. The goal of the proposed project is to develop two innovative circulatory support systems for children and infants based upon the unique proprietary and patented CircuLite Synergy Pocket Circulatory Assist Device. The success of these two devices will potentially benefit thousands of infants and children with congenital and acquired cardiovascular disease who otherwise would die each year in the United States while waiting for a donor heart.
| Wei, Xufeng; Li, Tieluo; Sanchez, Pablo G et al. (2013) Initial experience with a juvenile sheep model for evaluation of the pediatric intracorporeal ventricular assist devices [corrected]. ASAIO J 59:75-80 |
