The overall objective of this proposed program is the commercialization of the Pediatric Impella system, a minimally invasive ventricular assist device (VAD) for treatment of acute heart failure in pediatric patients. The device will be a less traumatic alternative to extracorporeal membrane oxygenation (ECMO), the current standard of care for these patients. The target patient population is in the age and weight range of 3 mos - 3 yrs and 5-15 kg. The Pediatric Impella system will be designed to unload the left ventricle and promote cardiac recovery, providing blood flow in the range of 0.5-2 lpm for up to 2 wks of support. Reviewers pointed out in discussion that the device is not as minimally invasive as claimed and will require more anticoagulation than is suggested in the application. Since there are only a few devices in the field for this problem, this proposal addresses a great unmet clinical need and has high significance.
It is estimated that approximately 9,000 infants born with congenital heart defects each year in the U.S. require some form of invasive intervention during the first years of life. Many of these children require mechanical circulatory support as a bridge to recovery or to transplant. Shorter duration of support (for days to at most a few weeks) for acute, generally recoverable heart failure is mostly provided by extracorporeal membrane oxygenation (ECMO). ECMO is highly invasive and is associated with a host of complications including blood clots, bleeding, ongoing heart failure, and strokes. Therefore, a strong unmet clinical need exists for a minimally invasive ventricular assist device (VAD) that can supplant ECMO for treatment of acute heart failure in pediatric patients.