An Artificial Myocardium for Pediatric Support

DESCRIPTION (provided by applicant): The ultimate objective of this proposed program is the commercialization of a neonate 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 small infants who are critically ill with heart failure. This is in spite of the fact that most cases for cardiac support via extracorporeal membrane oxygenation (ECMO) are for infants following complex surgical reconstructions for congenital defects. An aggressive development schedule for a pediatric VAD is proposed. The necessary characterization of the VAD will be completed for a submission to the FDA for approval as a humanitarian use device (HUD). The clinical indication sought for the device will be for short-term use to bridge to recovery following complex surgical reconstruction for congenital defects. Specifically, the target population is neonates with a single functional ventricle anatomy undergoing life saving surgery. A significant fraction of these patients either have difficulty weaning from cardiopulmonary bypass, or have cardiac failure after coming off bypass requiring the use of high levels of inotropes. The VAD is a pericardial wrap that contracts around the ventricle to provide cardiac support. The use of a short term, minimally invasive VAD should have a major benefit for these weakened patients. The device developed here will be implanted either at the time of surgery, or on an emergent basis for cardiac rescue and assist. The device developed will fill a large hole in the current public health care system. Pediatric VADs for the neonate population are neither currently available nor being developed for clinical use, despite this patient population having the highest need. The current technology used for this patient population, ECMO has an associated high morbidity. Funding the development of the neonate VAD will follow recent federal guidelines related to orphan product development of necessary medical devices with relatively small market potential. ABIOMED, as a leader in cardiac assist, will provide the technical expertise to develop the needed device.