CorMatrix(R) Announces FDA 510(k) For Novel Biomaterial Implant For Intracardiac Repair

The CorMatrix ECM is made from small intestinal submucosa derived from pig jejunum and stimulated the patient's natural healing mechanisms with collagen...the tissue in time replaces the graft, thus it appears this is done once and then it is left up to the body....4000 or more have had the procedure at over 160 US hospitals. BD

CorMatrix Cardiovascular, Inc., an Atlanta- based company dedicated to developing and delivering unique extracellular matrix (ECM(TM)) biomaterial technologies that harness the body's innate ability to repair damaged cardiovascular tissue, announced that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CorMatrix ECM(TM) for Cardiac Tissue Repair, which utilizes the company's proprietary ECM Technology(TM).

Following implantation by a surgeon, CorMatrix ECM Technology products act as a scaffold into which the patient's own cells migrate and integrate, stimulating the body's innate wound-healing mechanisms to repair tissue at the site of implantation. As the patient's cells populate the matrix they lay down their own collagen, which matures over time to form a functional tissue repair. The implanted ECM material is gradually replaced and resorbed by the body as the patient's tissue is remodeled.