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 system for extended application of counterpulsation therapy for heart failure. The system consists of a 32-ml counterpulsation device (CPD) that is designed to be implanted via a surface operation in the shoulder area (pacemaker pocket). The CPD, a blood sac, is anastamosed to the subclavian artery. A driver for controlling device inflation/deflation timing carried externally allowing complete patient mobility. Preliminary testing with a first generation prototype driver was conducted in mock circulation system and acute animal experiments to define driver performance characteristics. The driver was then re-designed to reduce size and weight, improve force of counterpulsation delivery, increase response to higher heart rates, and extend device longevity. The CPD driver is in fabrication and ready for in vivo testing. The goal of this Phase I SBIR proposal is to compare the hemodynamic efficacy of the 32-ml CPD system (device and driver) to a 40- ml IABP system (catheter and driver). We will also demonstrate that engineering specifications of the new driver are met. This will be accomplished by completing the following specific aim: Aim-1: To demonstrate the efficacy of a 32-ml CPD driver in reducing ventricular afterload and augmenting diastolic perfusion to the heart and vasculature under a variety of clinically-relevant conditions - hypertension, hypotension, and heart failure. Our hypothesis is that the performance of the CPD system will be similar to a standard clinically-available IABP system. If successful, in Phase II we will conduct driver reliability testing controller reliability testing and chronic in vivo testing to demonstrate the long-term effectiveness of the 32-ml CPD system. SCR, Inc. (Louisville, KY) is developing a novel mechanical device to treat early stage heart failure patients. The device can be implanted using a simple surgical procedure comparable to a pacemaker. Since comparable devices can only provide up to 2 weeks of support, SCR is proposing to develop a portable, pneumatic driver to provide up to two years of support.

Thesaurus Terms:
auxiliary heart prosthesis, biomedical equipment development, circulatory assist, clinical biomedical equipment, heart failure, portable biomedical equipment aortic balloon pump, biomedical equipment safety, cardiovascular disorder therapy, hemodynamics, miniature biomedical equipment, nonhuman therapy evaluation cow, medical implant science

SCR, Inc. (Louisville, KY) is developing a chronic implantable CPD system to treat HF patients who may be responsive to long-term counterpulsation support. The CPD has been developed for superficial implantation via a pacemaker incision without the need to enter the chest and enables complete patient mobility. The CPD is a 32-ml stroke volume polyurethane-lined blood chamber designed to fit comfortably in a subcutaneous pocket on the right anterior chest contralateral to an implantable cardioverter defibrillator (ICD) or biventricular pacer device implantation site. The pumping chamber is connected to the systemic circulation by a short ePTFE graft anastomosed to the axillary artery. The CPD is controlled by a small, wearable pneumatic driver, connected by a percutaneous air line, and triggered by the patient's 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 driver was equivalent to a standard commercially-available 40-ml IABP in a large animal model (n=12) over a range of physiologic conditions (hypotension, hypertenstion, and heart failure) demonstrating feasibility. In this phase II study, the development and testing of the CPD driver will be completed to support a future FDA submission. This objective will be accomplished by (1) completing engineering development, (2) demonstrating reliability and ergonomics, and (3) demonstrating long-term safety of the CPD driver. 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 program detailed here leverages the development work of SCR and the engineering and development teams at Abiomed (Danvers, MA). This partnership will be assisted and guided by an innovative group of physicians at Jewish Hospital (Louisville, KY) 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 system into the clinic as a long-term counterpulsation therapy to treat late NYHA class III and early NYHA class IV HF patients and help restore their quality of life.

Public Health Relevance:
SCR, Inc. (Louisville, KY) 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 a portable pneumatic driver that the patient can carry restores mobility.

Public Health Relevance Statement:
SCR, Inc. (Louisville, KY) 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 a portable pneumatic driver that the patient can carry restores mobility.

Project Terms:
Acute; Air; Anastomosis; Anastomosis - action; Animal Model; Animal Models and Related Studies; Anterior; Axillary Artery; Blood; Blood Circulation; Blood Pressure, High; Blood Pressure, Low; Bloodstream; Cannulas; Cardiac; Cardiovascular; Cardiovascular Body System; Cardiovascular system; Cardiovascular system (all sites); Carotid Arteries; Catheters; Chest; Chronic; Circulation; Clinic; Clinical; Clinical Trials; Clinical Trials, Phase I; Clinical Trials, Phase II; Clinical Trials, Unspecified; Contralateral; Coronary; Counterpulsation; Data; Defibrillators, Implantable; Development; Devices; Diastole; Dysfunction; ECG; EKG; Early-Stage Clinical Trials; Electrocardiogram; Electrocardiography; Engineering; Engineerings; FDA; Food and Drug Administration; Food and Drug Administration (U.S.); Functional disorder; Future; Goals; HOSP; Heart; Heart failure; Hospitals; Hypertension; Hypotension; Implant; Implantable Cardioverter-Defibrillators; Implantable Defibrillators; In Vitro; Institutes; Intra-Aortic Balloon Pumping; Intraaortic Balloon Pumping; Jewish; Jewish, follower of religion; Location; Mechanics; Modification; Myocardial; Operation; Operative Procedures; Operative Surgical Procedures; Organ; Organ System, Cardiovascular; Ostamer; Otomy; Pace Stimulators; Pacemakers; Patients; Pellethane; Performance; Perfusion; Phase; Phase 1 Clinical Trials; Phase 2 Clinical Trials; Phase I Clinical Trials; Phase I Study; Phase II Clinical Trials; Physicians; Physiologic; Physiological; Physiopathology; Polyisocyanates; Polyurethanes; Programs (PT); Programs [Publication Type]; Pump; QOL; Quality of life; Research; Reticuloendothelial System, Blood; Right-On; Safety; Site; Social Support System; Staging; Stimulators, Electrical, Pace; Stroke Volume; Structure of axillary artery; Summary Reports; Support System; Surgical; Surgical Interventions; Surgical Procedure; Surgical incisions; System; System, LOINC Axis 4; Systole; Testing; Thorace; Thoracic; Thoracic aorta; Thorax; USFDA; United States Food and Drug Administration; Universities; Validation; Vascular Hypertensive Disease; Vascular Hypertensive Disorder; Vascular Hypotensive Disorder; Vascular, Heart; Ventricular; Weight; Work; Work Load; Workload; biocompatibility; biomaterial compatibility; cardiac failure; circulatory system; clinical investigation; clinical relevance; clinically relevant; design; designing; ergonomics; experiment; experimental research; experimental study; follower of religion Jewish; good laboratory practice; hemodynamics; hyperpiesia; hyperpiesis; hypertensive disease; implantation; improved; in vivo; incision; innovate; innovation; innovative; model organism; pathophysiology; phase 1 study; phase 1 trial; phase 2 study; phase 2 trial; phase I trial; phase II trial; pre-clinical; preclinical; programs; protocol, phase I; protocol, phase II; public health relevance; research study; study, phase II; subcutaneous; surgery