Development of a pediatric, long-term, minimally invasive circulatory support device (PediPulse) to treat heart failure

ABSTRACT Therapeutic options for heart failure in the pediatric population are severely limitedPediatric patients requiring mechanical circulatory supportMCShave very high mortality and adverse event ratesRecognizing this critical therapeutic gapthe National HeartLungand Blood InstituteNHLBIlaunched the PumpKINPumps for KidsInfants and Neonatesinitiative inwhich led to the development of pediatric MCS devicesHoweverclinical challenges associated with long term pediatric support still remain as implantable MCS devices developed under the PumpKIN program have failed to be commercializedClinicians currently depend on the Berlin Heart EXCOR pediatric devicewhich severely limits ambulation and precludes hospital dischargeor adult MCS devicesused off labelwhich require a complex and invasive implant explant proceduresternotomy with cardiopulmonary bypassin pediatric anatomiesMCS using counterpulsation with intra aortic balloon pumpsIABPis simpleeasy to implantand widely used in adultsCounterpulsation provides important clinical benefits for the heartlower afterloadreduced ventricular workloadand increased coronary flowand increases cardiac output and end organ perfusionHowevertranscutaneous insertionischemia at the peripheral femoral artery insertion siteand durability of the IABP catheter limits its application to short durationsConsequentlycounterpulsation has not gained widespread acceptance as a long term therapy to treat pediatric heart failure !! To overcome these limitationsinvestigators at NuPulseCVRaleighNCis developing a chronic counterpulsation devicePediPulsefor pediatric supportPediPulse can be implanted using minimally invasive surgical techniques without the need to enter the chestThe device is actuated by a smallwearable pneumatic driver through a percutaneous air line and triggered by the patient s ECG via subcutaneous ECG leadsThe PediPulse system has the advantages of being ambulatorynon thrombogenic that enables the patient to turn their supportonoroffas needednon obstructivelow cost with low serious adverse event rate burdenless invasiveand able to be implanted in a less sick pediatric heart failure population that may increase potential for myocardial recoveryIn this SBIR phase I proposalwe will demonstrate feasibility of the pediatric PediPulse by evaluating virtual anatomic fit from pediatric CT scansand investigating device effectiveness and performance in acutenandday chronicnjuvenilemonthmale and femaleovine modelsUpon successful demonstration of feasibilitywe plan to submit a phase II proposal to complete development and conduct verification validation and pre clinical animal studies to support an Investigational Device ExemptionIDEapplication to the Food and Drug AdministrationFDAfor clinical trials in pediatric heart failure patients NARRATIVE NuPulseCV IncRaleighNCis developing a long termmechanical circulatory support devicePediPulseto augment cardiac output and support pediatric patients with heart failureTherapeutic mechanical circulatory support options for pediatric patients are severely limited by dependence upon adult deviceswhich require invasive open heart surgeryand complex post op careresulting in high mortality ratesThe 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