Therapeutic options for heart failure in the pediatric population are severely limited. Pediatric patients requiring mechanical circulatory support (MCS) have very high mortality and adverse event rates. Recognizing this critical therapeutic gap, the National Heart, Lung, and Blood Institute (NHLBI) launched the PumpKIN (Pumps for Kids, Infants and Neonates) initiative in 2004 which led to the development of pediatric MCS devices. However, clinical challenges associated with long-term pediatric support still remain as implantable MCS devices developed under the PumpKIN program have failed to be commercialized. Clinicians currently depend on the Berlin Heart EXCOR pediatric device, which severely limits ambulation and precludes hospital discharge, or adult MCS devices (used off-label), which require a complex and invasive implant/explant procedure (sternotomy with cardiopulmonary bypass) in pediatric anatomies. MCS using counterpulsation with intra-aortic balloon pumps (IABP) is simple, easy to implant, and widely used in adults. Counterpulsation provides important clinical benefits for the heart (lower afterload, reduced ventricular workload, and increased coronary flow) and increases cardiac output and end-organ perfusion. However, transcutaneous insertion, ischemia at the peripheral femoral artery insertion site, and durability of the IABP catheter limits its application to short durations. Consequently, counterpulsation has not gained widespread acceptance as a long-term therapy to treat pediatric heart failure.!! To overcome these limitations, investigators at NuPulseCV (Raleigh, NC) is developing a chronic counterpulsation device (PediPulse) for pediatric support. PediPulse can be implanted using minimally invasive surgical techniques without the need to enter the chest. The device is actuated by a small, wearable pneumatic driver through a percutaneous air-line and triggered by the patient?s ECG via subcutaneous ECG leads. The PediPulse system has the advantages of being ambulatory, non-thrombogenic that enables the patient to turn their support ?on? or ?off? as needed, non-obstructive, low-cost with low serious adverse event rate burden, less invasive, and able to be implanted in a less sick pediatric heart failure population that may increase potential for myocardial recovery. In this SBIR phase I proposal, we will demonstrate feasibility of the pediatric PediPulse by evaluating virtual anatomic fit from pediatric CT scans, and investigating device effectiveness and performance in acute (n=4) and 14-day chronic (n=2) juvenile (2-4 month, male and female) ovine models. Upon successful demonstration of feasibility, we plan to submit a phase II proposal to complete development and conduct verification/validation and pre-clinical animal studies to support an Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA) for clinical trials in pediatric heart failure patients.
NuPulseCV Inc. (Raleigh, NC) is developing a long-term, mechanical circulatory support device (PediPulse) to augment cardiac output and support pediatric patients with heart failure. Therapeutic mechanical circulatory support options for pediatric patients are severely limited by dependence upon adult devices, which require invasive open-heart surgery, and complex post-op care, resulting in high mortality rates. The PediPulse system can be implanted using a less invasive surgical approach without the need to enter the chest and is designed to be implanted in children to improve patient outcomes and restore quality of life.
