Drug-Eluting Biomaterials & Tissue Engineering

Every year in the US 5,000,000 people show aspects of congestive heart failure, and 550,000 new cases of advanced heart failure are diagnosed. Over a million die within two years of diagnosis. Currently, approaches to improving the outcome of heart failure are limited. Furthermore, peripheral vascular disease (PVD), defined as a non-coronary artery disease, is prevalent and associated with coronary artery disease. Despite significant morbidity and mortality related to PVD, myocardial infarction and associated heart-related mortalities remain the leading cause of death for PVD patients. Restenosis, that is, the reclosure of a blood vessel, is a common complication in peripheral vascular surgery, limiting the treatment. The blockage can be by-passed by attaching a synthetic tube or natural vessel in front of the blockage and reattaching it just beyond the blockage, thus allowing blood to bypass the blocked section of vessel. Surgical bypass is effective in large blood vessels; however, in smaller vessels restenosis frequently occurs.

Over 250,000 by-passes, excluding coronary by-pass surgery occur annually in the US; 40% of these show restenosis at five years. Surgery causes injury to the vessel that induces scar tissue formation from the injured areas. The scar tissue often causes restenosis at one end of the graft.

Covalon's proprietary technology platforms have created significant potential for new drug eluting products, and tissue engineering biomaterials.