The ultimate objective of this proposal is the commercialization of a pediatric ventricular assist device (VAD). Although, VADs, both implantable and paracorporeal, have become an important surgical option for adult patients with myocardial failure unresponsive to less aggressive therapy, no VADs are commercially available for short-term use in children or small infants who are critically ill with heart failure. This may be primarily due to the fact that the potential number of total cases remains small, especially in regard to the high costs necessary for the development of a viable commercially available product. An aggressive product development program for a pediatric VAD is proposed here. The end-point of the program will be an FDA submission for the first ever U.S. clinical trial for a pediatric VAD to be tested at a leading pediatric cardiac surgical center. The clinical indication for the device will be for temporary use either to allow myocardial healing and/or recovery (so-called bridge-to-recovery (B2R)), or to provide adequate blood flow in patients suffering from irreversible heart failure while awaiting heart transplantation (so-called bridge-to-transplantation (B2T)). The VAD being developed here will have several advantages over the current method used for short-term pediatric cardiac support (i.e., centrifugal pumps, usually with extracorporeal membrane oxygenation (ECMO)). The design chosen will provide pulsatile flow without issues related to either blood volume or thrombus formation. The Phase I study will demonstrate feasibility of the VAD design. Phase II will primarily involve readiness testing and detailed animal studies to support an FDA approved Investigational Device Exemption (IDE). This effort will be accomplished in tandem with a leading pediatric cardiac team at Miami Children's Hospital, who will be pivotal in the planning of the initial clinical trial.
