Small diameter-biological vascular graft materials currently available for below-knee peripheral vascular reconstruction in patients with arterial obstructions are limited. Allogeneic and autologous saphenous vein is often used but the availability of suitable conduit limits autologous procedures, and the supply of allograft vein is dependent upon tissue donations. To increase the supply of current biological grafts, and to meet the projected future demand for peripheral bypass conduit material, the development of alternative graft materials is necessary. This proposal outlines a development strategy for a new biological conduit, suitable for below-knee peripheral revascularization. This graft will be manufactured from animal tissues that are available in large quantities and can be processed to remove foreign antigens relatively inexpensively. The resulting graft will comprise a biological tissue matrix, capable of being remodeled by the patient's own cellular components. In order to bring this product through development, to submission of the regulatory documents required to initiate clinical testing, a specific battery of in vitro and in vivo tests will be carried out. These tests begin with cell culture experimentation to demonstrate remodeling, and progress into toxicology and mechanical strength measurements. Finally safety and efficacy testing will be performed by implantation in laboratory animals.
Testing of this graft is designed to meet device requirements by the regulatory agencies in both the United States and Europe. As a xenogeneic biological vascular graft has the potential to be used in all below-knee peripheral vascular reconstructions, there would be a potential annual market of approximately 105,000 cases in US alone. With additional sales in Europe, the market would be far greater.
