FDA Clears CorMatrix ECM for Vascular Repair

CorMatrix Cardiovascular Inc. has received U.S. Food and Drug Administration (FDA) clearance to market its CorMatrix ECM for vascular repair.

The CorMatrix ECM product is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. The device may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels. It is constructed from a multi-laminate sheet of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) derived from porcine small intestinal submucosa.

“CorMatrix ECM for Vascular Repair is a scaffold permitting the patient’s own stem cells to regenerate viable autogenous tissue improving the results of revascularization procedures that often fail due to myointimal hyperplasia and accelerated atherosclerosis,” said Richard F. Neville, M.D., professor of Surgery and chief of the Division of Vascular Surgery at George Washington University in Washington, D.C.

“The CorMatrix ECM for Vascular Repair is an expansion of the current indications for our CorMatrix ECM for Carotid Repair and was pursued due to requests by our physicians for a product that could be used to repair blood vessels throughout the vascular system. CorMatrix devices have now been used in over 100,000 patients worldwide to treat a growing number of cardiovascular indications. We are pleased that we can address these additional requests by physicians, providing a device to meet current clinical needs,” said Andrew Green, CorMatrix Cardiovascular’s executive vice president of Operations. “Expansion of our current FDA-cleared devices to satisfy unmet indications further strengthens our position in the field of ECM technologies and regenerative medicine, utilizing the patient’s own stem cells and their natural healing ability.”

Based in Atlanta, Ga., CorMatrix Cardiovascular was founded in 2001 as a privately held medical device company dedicated to developing and delivering biomaterial devices that harness the body’s ability to repair damaged cardiovascular tissues. CorMatrix ECM is designed for a variety of cardiovascular indications, and has U.S. clearance and European approval (with a CE Mark) for its ECM technology as an implant for pericardial closure, cardiac tissue repair, as well as clearance for carotid repair.