(P. Lelkes, R. Levy, and R. Composto)

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Abstract: Peripheral vascular disease is a widespread clinical problem, accounting for more than one million vascular graft surgeries each year in the United States. To date, attempts to develop a small-bore synthetic coronary artery graft (≤ 5 mm inner diameter) have been unsuccessful largely due to thromboembolic complications (clotting), incompatible, synthetic blood-contacting graft surfaces, and/or neointimal hyperplasia originating at the sites of anastomosis. Novel synthetic small vessel substitutes are needed because existing technologies for large vessel conduits cannot be reproduced for small diameter grafts, and small diameter grafts using the old paradigm and materials fail at clinically unacceptable rates. We have created a novel medical device, operationally termed the LCL Graft™, which is a highly compliant small caliber vascular graft made of improved, oxidation-resistant polyurethane with physical and chemical modifications to its micropatterned luminal surface designed to concomitantly limit thrombogenicity and enhance endothelial cell attachment. The LCL Graft™ will be easily packaged and marketed due to its extended shelf life and will be readily available for use by surgeons as is, or following endothelialization of the graft using cell therapy selected by the physician prior to the procedure or directly in the operating room. Similarly, the same technology can be used to produce a coronary bypass graft with or without endothelial. We anticipate that our product will significantly improve the clinical outcomes of small-bore grafts for use as coronary bypass grafts and in the peripheral circulation.

The LCL Graft technology is available for licensing for vascular grafting applications. It has been exclusively licensed to an established company for use in combination with vascular stents.