Development of a Counterpulsation Therapy Device

DESCRIPTION (provided by applicant): 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 vol ume, 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 eject s 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 thi s 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) de monstrating 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 p repared 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 partner ship 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 i s 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.