Heart failure (HF) rapidly progresses despite optimal medical management and cardiac resynchronizationtherapy. 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), whichmay 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 percutaneousimplantation in the descending aorta in a cardiac catheter laboratory by a cardiologist within 1.5 hours, andenables complete patient mobility. In an ongoing FDA approved clinical study, the first-generation iVAS wassuccessfully implanted in over 80 patients using a surgical approach and demonstrated statistically significanthemodynamic 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 cardiacsurgeon and two assistants to implant the device, takes ~4 hours to implant, and requires a surgical suite. Inthis SBIR Phase I study, we will demonstrate feasibility of a percutaneously delivered second-generation iVASto provide chronic counterpulsation support.This objective will be accomplished by (1) fabrication of the second generation iVAS and implant toolsdesigned 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 SBIRPhase 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 ofNuPulseCV 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 settingas a long-term counterpulsation therapy to treat heart failure patients with minimal adverse events and helprestore their quality of life.
Public Health Relevance Statement: NARRATIVE
NuPulseCV (Raleigh, NC) is developing a second-generation, percutaneously implanted, 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 requiring only a minimally invasive percutaneous implantation procedure in a cardiac
catheter lab, and enables quick discharge and patient ambulation to restore quality of life.
Project Terms: mechanical ; Mechanics ; Hour ; Complex ; subdermal ; subcutaneous ; System ; Ejection Fraction ; EFRAC ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; Medical center ; Surgeon ; Devices ; Social Support System ; Support System ; Adverse Experience ; Adverse event ; Skin ; Diameter ; Caliber ; International ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Ventricular ; Cardiac ; Development ; developmental ; Image ; imaging ; pre-clinical ; preclinical ; cost ; design ; designing ; coronary perfusion ; Population ; innovation ; innovate ; innovative ; Resistance ; resistant ; Implant ; implantation ; FDA approved ; minimally invasive ; product development ; verification and validation ; phase 1 study ; Phase I Study ; Secure ; cardiac resynchronization therapy ; left ventricular assist device ; LVAD ; patient mobility ; sheep model ; ovine animal model ; ovine model ; Home ; Adult ; 21+ years old ; Adult Human ; adulthood ; Air ; Animals ; axillary artery ; Blood Vessels ; vascular ; Cardiac Output ; heart output ; Clinical Investigator ; Clinical Research ; Clinical Study ; Clinical Trials ; Counterpulsation ; Descending aorta ; Electrocardiogram ; ECG ; EKG ; Electrocardiography ; Engineering ; femoral artery ; Freezing ; Heart failure ; cardiac failure ; Cardiac Surgery procedures ; Cardiac Surgery ; Cardiac Surgical Procedures ; Heart Surgical Procedures ; heart surgery ; hemodynamics ; Hemostatic function ; Hemostasis ; Hemostatic Agents ; Hemostatics ; implantable device ; biomedical implant ; implant device ; indwelling device ; Implantation procedure ; implant placement ; implant procedure ; indexing ; Intra-Aortic Balloon Pumping ; Intraaortic Balloon Pumping ; Ischemia ; Israel ; Laboratories ; Lead ; Pb element ; heavy metal Pb ; heavy metal lead ; mortality ; Patients ; Physicians ; Quality of life ; QOL ; Safety ; Technology ; Testing ; Work ; Generations ; Workload ; Work Load ; Catheters ; Treatment Cost ; Caring ; Pump ; Procedures ; Site ; Surface ; Acute ; Chronic ; Clinical ; Phase ; Medical ; Therapeutic ; tool ; programs ;
