Despite the wide acceptance of percutaneous transluminal angioplasty (PTA) and intravascular stenting for treating patients with peripheral atherosclerotic lesions, these techniques suffer some drawbacks, which, limit their overall clinical success. A high rate of restenosis remains the major complication of PTA and intravascular stenting procedures. The overall goal of this research is to design, develop and test in vivo a novel collagen-based endoprosthesis (CBE) for reducing the rate of post-PTA restenosis. In the phase I investigation, we have designed and developed a CBE prototype that can be reliably delivered by standard transluminal percutaneous intervention techniques. The CBE prototype had a superior patency rate compared to an ePTFE vascular graft-based endoprosthesis prototype in a canine femoral artery model. In the phase II, we will further improve the design of the CBE, and evaluate the in vivo performance of the CBE in an atherosclerotic animal model. Upon completion of the phase II research, we will continue the phase III program and actively pursue clinical trials and commercialization of the CBE device.
There were more than 150,000 percutaneous transluminal angioplasty (PTA) procedures performed to treat patients with peripheral atherosclerotic lesions in the U.S. in 1995 alone. The occurrence of late restenosis typically lead to reinterventions that result in a significant increase of the total costs of patient care. If the proposed endoprosthesis device functions well, a 5% reduction of the restenosis rate can be translated into a savings of more than $100 million dollars a year in the associated healthcare costs.
