Development of a percutaneously implantable, ambulatory, long-term intravascular ventricular assist system

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ABSTRACT 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 percutaneously delivered, chronic implantable, second-generation counterpulsation system (iVAS) to treat HF patients. The NuPulseCV iVAS has been developed for less invasive percutaneous implantation in the descending aorta in a cardiac catheter laboratory by a cardiologist within 1.5 hours, and enables complete patient mobility. In an ongoing FDA approved clinical study, the first-generation iVAS was successfully implanted in over 80 patients using a surgical approach and demonstrated statistically significant hemodynamic improvements in cardiac index (39%), ejection fraction (48%), and cardiac power index (35%) over baseline values. However, the first-generation iVAS used for the clinical studies requires a cardiac surgeon and two assistants to implant the device, takes ~4 hours to implant, and requires a surgical suite. In this SBIR Phase I study, we will demonstrate feasibility of a percutaneously delivered second-generation iVAS to provide chronic counterpulsation support. This objective will be accomplished by (1) fabrication of the second generation iVAS and implant tools designed for percutaneous delivery, (2) demonstrating feasibility using acute and chronic ovine models. Results from the SBIR Phase I study will be used for optimization of the percutaneous iVAS 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 Beth Israel Deaconess Medical Center (BIDMC). Our long-term objective is to successfully introduce the second generation iVAS 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.