Development towards treating small children and infants with mechanical circulatory support systems to bridge to transplant purposes is underway. However, implantable systems with miniaturized external components have delayed the process. To date, the need for mechanical circulatory support systems for infant and children with congenital and acquired cardiovascular disease has largely been unmet. In the United States, hundreds of infant and children die each year while waiting for a donor heart. The goal of this "Fast Track" SBIR application is to develop a miniaturized controller module and other external components for both CircuLite's Infant and Child Circulatory Support Systems. Leveraging our proprietary and patented adult Synergy external components, refinements to the software and hardware will be made to produce miniature components for infants and small children. The goal of the Phase I project is to demonstrate the feasibility of modifying the current software and hardware used for the Synergy patient controller to provide fail - safe redundant operating mode. In Phase II, the software and hardware will be integrated to complete a miniaturized beta prototype of the pediatric controller. Additionally, the accessory components will be designed and fabricated to aid in patient mobility while supported by the systems. The milestones for Phase I will be the delivery of an alpha prototype of the fail - safe pediatric controller. In Phase II, we will deliver a miniature beta prototype of the controller, complete a human factors study and test the complete Child System in short-term animal studies to assess the functionality and durability of the newly integrated system.
Long-term pediatric cardiovascular mechanical support for infants and small children is an area that has largely been unfulfilled by medical device companies. The primary goal of this proposal will be to refine the software and miniaturize the hardware of the patient controller of both CircuLite's Infant and Child Circulatory Support Systems. These systems will provide an opportunity to bridge the hundreds of infants and small children to transplant each year who may otherwise die while waiting for a donor heart.