Development of a lightweight, portable, pneumatic drive unit for long term counterpulsationsupport

ABSTRACT Heart failureHFrapidly progresses despite optimal medical management and cardiac resynchronization therapyLeft ventricular assist devices are reserved only for end stage HF due to surgical invasivenessLongterm mechanical circulatory support options for less sick heart failure patientsClass IIIearly Class IVwhich may slow down or reverse HF progressionare limitedTo fulfill this therapeutic gapNuPulseCVRaleighNCis developing a chronic implantable counterpulsation systemiVASto treat HF patientsThe NuPulseCV system has been developed for less invasive implantation in the descending aorta without the need to enter the chest and enables complete patient mobilityIn an ongoing Food and Drug AdministrationFDAapproved clinical studythe iVAS was successfully implanted in overpatients and improved patient hemodynamics as evidenced by statistically significant improvements in cardiac indexejection fractionand cardiac power indexover baseline valuesHoweverthe first generation NuPulseCV drive unitNDUused for the clinical studies is a feasibility model that is not durableexpensive to manufacturebulkyand not ergonomiclimiting patient mobility and ambulatory useIn this SBIR Phase I studywe will demonstrate feasibility of a durablelight weight and ergonomic second generation NDU to provide effective counterpulsation supportThis objective will be accomplished byfabrication of the second generation NDU using previously identified components to reduce sizeweightnoiseand improving NDU performancedemonstrating feasibility using mock loopand acute and chronic ovine modelsResults from the SBIR Phase I study will be used for optimization of the NDU during SBIR Phase IIwhich will then lead to an FDA submission for a pivotal studyThe program detailed in this proposal leverages the engineering expertise and development work of NuPulseCV guided by an innovative group of physicians at Duke UniversityDurhamNCOur long term objective is to successfully introduce the portable and ergonomic NuPulseCV system into the clinical setting as a long term counterpulsation therapy to treat heart failure patients with minimal adverse events and help restore their quality of life NARRATIVE NuPulseCVRaleighNCis developing a long termmechanical circulatory support systemiVASto augment cardiac output and treat heart failure patientsCurrent mechanical circulatory support options are reserved only for advanced heart failure patients due to invasiveness of device implantopen heart surgeryand complex post op careresulting in high mortality rates and treatment costsThe NuPulseCV iVAS system enables treatment of a less sick heart failure populationNYHA Class III IVbyrequiring only a minimally invasive implantation without the need to enter the chestandusing a portablelightweightpneumatic driver that the patient can carry to restore mobility and quality of life