Heart failure (HF) rapidly progresses despite optimal medical management and cardiac resynchronization therapy. Left ventricular assist devices are reserved only for end-stage HF due to surgical invasiveness. Long- term mechanical circulatory support options for less sick heart failure patients (Class III, early Class IV), which may slow down or reverse HF progression, are limited. To fulfill this therapeutic gap, NuPulseCV (Raleigh, NC) is developing a chronic implantable counterpulsation system (iVAS) to treat HF patients. The NuPulseCV system has been developed for less invasive implantation in the descending aorta without the need to enter the chest and enables complete patient mobility. In an ongoing Food and Drug Administration (FDA) approved clinical study, the iVAS was successfully implanted in over 50 patients and improved patient hemodynamics as evidenced by statistically significant improvements in cardiac index (39%), ejection fraction (48%), and cardiac power index (35%) over baseline values. However, the first-generation NuPulseCV drive unit (NDU) used for the clinical studies is a feasibility model that is not durable, expensive to manufacture, bulky, and not ergonomic, limiting patient mobility and ambulatory use. In this SBIR Phase I study, we will demonstrate feasibility of a durable, light-weight and ergonomic second-generation NDU to provide effective counterpulsation support. This objective will be accomplished by (1) fabrication of the second generation NDU using previously identified components to reduce size, weight, noise, and improving NDU performance, (2) demonstrating feasibility using mock loop, and acute and chronic ovine models. Results from the SBIR Phase I study will be used for optimization of the NDU during SBIR Phase II, which will then lead to an FDA submission for a pivotal study. The program detailed in this proposal leverages the engineering expertise and development work of NuPulseCV guided by an innovative group of physicians at Duke University (Durham, NC). Our 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.
Public Health Relevance Statement: NARRATIVE NuPulseCV (Raleigh, NC) is developing a long-term, mechanical circulatory support system (iVAS) to augment cardiac output and treat heart failure patients. Current mechanical circulatory support options are reserved only for advanced heart failure patients due to invasiveness of device implant (open-heart surgery), and complex post-op care, resulting in high mortality rates and treatment costs. The NuPulseCV iVAS system enables treatment of a less sick heart failure population (NYHA Class III/IV) by (1) requiring only a minimally invasive implantation without the need to enter the chest, and (2) using a portable, lightweight, pneumatic driver that the patient can carry to restore mobility and quality of life.
NIH Spending Category: Assistive Technology; Bioengineering; Cardiovascular; Heart Disease
Project Terms: Acute; Adult; Adverse event; Air; Aorta; blood pump; Caliber; Cardiac; Cardiac Output; cardiac resynchronization therapy; Cardiac Surgery procedures; Caring; Catheters; Chest; Chronic; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Complex; coronary perfusion; cost; Counterpulsation; Descending aorta; design; Development; Devices; EFRAC; Electrocardiogram; Engineering; femoral artery; Freezing; Generations; Goals; Heart failure; hemodynamics; Home environment; Implant; implantable device; implantation; improved; indexing; innovation; International; Intra-Aortic Balloon Pumping; Ischemia; Lead; left ventricular assist device; light weight; Mechanics; Medical; minimally invasive; Modeling; mortality; Noise; Operative Surgical Procedures; patient mobility; Patients; Performance; Phase; phase 1 study; Physicians; Population; portability; pre-clinical; Procedures; product development; programs; Pump; Quality of life; Safety; Sheep; Site; Small Business Innovation Research Grant; Structure of subclavian artery; subcutaneous; Support System; System; Technology; Testing; Therapeutic; Treatment Cost; United States Food and Drug Administration; Universities; Ventricular; verification and validation; Weight; Work; Workload
