SBIR-STTR Award

The incidence of congestive heart failure (CHF) is increasing worldwide with over one million new cases diagnosed annually. Over the past 30 years, counterpulsation with an intra-aortic balloon pump (IABP) has been widely and successfully used as a short-term treatment for cardiac dysfunction. However, counterpulsation is limited by its location within the descending thoracic aorta to short durations of therapy, typically less than 14 days. To overcome this limitation, Superficial Counterpulsation Research (SCR), Inc. has invented a novel device for long-term application of counterpulsation therapy for heart failure. The counterpulsation device (CPD) is designed to be implanted via a surface operation in the shoulder area (pacemaker pocket) by attaching it to the subclavian artery. This approach would give the patient nearly complete mobility. The first prototype CPD developed was a 40-ml valveless sac that fills and empties with each cardiac cycle. In acute studies in a calf with diminished cardiac function (DCF), the 40-ml CPD successfully reduced ventricular workload and augmented myocardial perfusion. In a cadaver fit study a problem with proper fit of the device in patients was revealed. To solve this problem, a smaller, second generation device (30-ml CPD) was developed. The 30-ml CPD provides a better fit and more comfortable implantation in the shoulder area, but its stroke volume is reduced by 25%, and this change requires verification that it can provide sufficient hemodynamic support. This 30-ml CPD is ready for in vivo testing. The goal of this Phase 1 SBIR proposal is to compare the hemodynamic efficacy of the new, ergonomic 30- ml CPD to the 40-ml CPD prototype. We will also demonstrate that the 30-ml CPD will not damage the artery or blood. This will be accomplished by completing the following specific aims: Aim-1: Demonstrate the efficacy of the 30-ml CPD in reducing ventricular workload and augmenting diastolic perfusion to the heart and vasculature in acute experiments using the DCF calf model. Aim-2: Perform a safety evaluation of the 30-ml CPD by examining possible pathological and hematologic changes in the artery and blood (i.e. hemolysis). In Phase II, we will propose chronic in vivo testing (30-day and 90-day DCF calf model) to demonstrate long-term effectiveness of the 30-ml CPD

SCR, Inc. (Louisville, KY) has developed a long-term implantable counterpulsation device (CPD) to treat heart failure (HF) patients who may be responsive to a milder form of cardiac assist. The CPD is 32-ml stroke volume, valveless pneumatically-driven blood sac with a single inflow/outflow cannula. The sac fits ergonomically in a `pacemaker pocket' and the graft is connected to the arterial system by an anastomosis to the subclavian artery. The CPD can be operated by a standard clinical pneumatic drive console (iPulse) or a small, wearable pneumatic driver (in development) connected to the sac by a percutaneous air line and timed to ECG. The CPD fills during native heart systole lowering ventricular workload, and ejects during diastole augmenting myocardial and end-organ perfusion. In the phase I study, the hemodynamic efficacy of the 32-ml CPD was comparable to a standard commercially-available 40-ml IABP in a large animal model (n=10) demonstrating feasibility. In this phase II study, the development and testing of the implantable components of the CPD system will be completed to support a future FDA submission. This objective will be accomplished by (1) completing engineering development and surgical procedure, (2) demonstrating reliability and hemocompatability, and (3) demonstrating long-term safety and biocompatibility of the implantable components of the CPD system. Results of a pivotal Good Laboratory Practices (GLP) study will be completed with a summary report prepared for submission to the Food and Drug Administration (FDA) to request approval for clinical trials. The proposed study leverages the development work of SCR, Inc and manufacturing and commercialization resources of Abiomed (Danvers, MA). This partnership will be guided by an innovative group of physicians at Jewish Hospital (Louisville, KY) and Advocate Christ Medical Center (Oak Lawn, IL) and a world class research team in the Cardiovascular Innovation Institute (CII) at the University of Louisville (UofL). Our long- term objective is to successfully introduce the CPD as a viable long-term therapy to treat late NYHA class III and early NYHA class IV HF patients to restore their quality of life and promote myocardial recovery. PUBLIC HEALTH RELEVANCE is developing a long-term counterpulsation device (CPD) to treat early stage heart failure patients. The CPD has been developed for superficial implantation without the need to enter the chest and enables complete patient mobility.

Public Health Relevance:
This Public Health Relevance is not available.

Thesaurus Terms:
There Are No Thesaurus Terms On File For This Project.