The development of a non-occluding, small diameter (4 mm or less) prosthetic vascular graft has been the focus of extensive research by scientists, clinicians and engineers. Although a variety of synthetic materials have been successful in applications requiring large diameter grafts, only autologous vessels provide clinically acceptable function for smaller grafts such as are required for coronary artery bypass surgery. The need to harvest autologous vessels increases the morbidity and costs associated with bypass procedures and, in some cases, patients do not suitable vessels available. The research outlined in this proposal will evaluate the use of a prosthetic vascular graft constructed from a biologically-derived collagen material. This intestinal collagen layer (ICL) is obtained from the submucosal layer of the porcine small intestine. ICL grafts provide the necessary mechanical properties for vascular graft applications but, unlike synthetic materials, they are designed to be remodeled by the host tissue. These studies will characterize that remodeling process in a rabbit model. PROPOSED COMMERCIAL APPLICATIONS: Arterial replacement is a common treatment for vascular disease with over 400,000 coronary grafts performed each year in the US. The availability of autografts is becoming increasingly limited as the number and complexity of coronary bypass procedures increase. Conservatively, the potential market for a small diameter, prosthetic vascular grafts would be in excess of 50,000 units per year, or 10% of all vascular grafting procedures in the US.
