BIOSURFACES INC — Department of Health and Human Services SBIR Phase I: PROJECT SUMMARY Cardiac valve repair or replacement is indicated when progression of degen

Description

PROJECT SUMMARY Cardiac valve repair or replacement is indicated when progression of degenerative disease or bacterial infection of the native valve results in valvular dysfunction, thereby impacting cardiac output. Both procedures require the use of a woven or knitted polyester material with an internal reinforcement (Teflon, silicone or metal) to either stabilize the native valve (annuloplasty ring) or to attach a prosthetic heart valve (sewing cuff). Bacterial infection (prosthetic valve endocarditis orPVE) is a major complication associated with implantation of these devices. Bacteremia seeded at the site prior to surgery or nosocomial infection acquired during the surgery or post-operatively are the primary routes of inoculation, resulting in significant morbidity and mortality. Since the functional parts of the mechanical valves are composed of metals, they are incapable of providing the environment for bacterial growth. Infection is typically localized to the prosthesis/tissue interface at the sewing