The applicants will continue the commercial development of the Heparin Removal Device (HRD) System to be used at the end of cardiopulmonary bypass in order to eliminate the use of protamine sulfate which can result in significant adverse reaction. Of the 600,000 open heart surgeries per year worldwide, as many as 25 percent of these patients are undergoing their second open heart surgery. Their prior exposure to protamine sulfate, as well as other indications, is increasingly putting this patient population at risk. The HRD System developed during the Phase I project, successfully demonstrated the ability of this device to intervene during the critical part of open heart surgery, significantly remove and separate plasma from the blood, allowing it to interact with a specific heparin removing sorbet and recombine the blood and return it back to the patient in a dehaparinized state. This small, relatively high flow, extracorporeal device (total surface area 0.2 m2, prime volume 185 m., operating at 600 ml/min) has undergone both safety and efficacy studies to evaluate its ability to be clinically used. The HRD System removes over 75 percent of circulating heparin in 15-20 minutes, with a total capacity of over 40,000 units removal. Phase II studies are being pursued to support the development of scale-up for production of the extracorporeal circuit and selective binding sorbet, and to support the animal training studies to qualify clinical centers to initiate human clinical trials and support the necessary regulatory submissions for an Investigational Device Exemption (IDE) approval from the FDA. Having demonstrated the proof of concept of this project, all safety and efficacy studies indicating its appropriate use for clinical application, these Phase II studies will be supporting both gear up of commercial production and clinical trials.
