SBIR Phase I: Development of device intended to direct growth of new blood vessels within a patient for treatment of cardiovascular diseases

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to determine the feasibility of a device for directed growth of a new blood vessel in patients with peripheral artery disease. The device is synthetic but is designed as a template to encourage a patient's own cells to form new tissue. After new tissue is formed, the device is absorbed by the body leaving a new blood vessel. Each year, approximately 1.4 million people in the United States require an arterial prosthesis to treat conditions of diseases including cardiovascular disease, peripheral artery disease, and diabetes. While many patients are able to use vessels from their own body, some must rely on other options including synthetic vascular prostheses. Currently available synthetic vascular prostheses are a notoriously poor option with up to 60% failing within 3 years. The proposed project will provide significant understanding of a novel technology that supports advanced treatments of vascular repair. This technology has the opportunity to help patients who continue to require additional surgical repair due to the poor performance of existing devices. This technology can capture a large share of the market for surgical vascular repair, which is over $4B worldwide. The proposed project explores the mechanical and biological attributes of a vascular template intended to direct the growth of new blood vessels within a patient and compares them with current standards for treatment of peripheral artery disease. Currently available synthetic vascular prosthesis have poor long term patency, which is attributed to the lack of confluent endothelial tissue formation. These devices have undergone little innovation and fail to adequately address the root cause leading to poor patency. In order to succeed, the template will need to first withstand the mechanical forces as a regular vascular prosthesis. These include burst pressure, and suture retention strength. In addition, the compliance of the template should be comparable to native blood vessels in order to decrease adverse effects after implantation. We will test our template for these values and make the necessary modifications. An animal study in pigs will then be used to compare our templates to the gold standard, a prosthesis made from native vessel. The animal study will allow us to answer critical questions about the cellular infiltration and tissue organization. We will use an FDA guidance document for vascular prosthesis as a guide for our studies to insure their relevance.