FDA clearance of CorMatrix ECM for vascular repair


CorMatrix Cardiovascular has announced that it has received US Food and Drug Administration (FDA) clearance to market the CorMatrix ECM (extracellular matrix) for vascular repair.

The CorMatrix ECM for vascular repair 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 CorMatrix ECM for vascular repair 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 decellularised, non-crosslinked, lyophilized extracellular matrix derived from porcine small intestinal submucosa.


According to Richard F Neville, professor of surgery, chief, Division of Vascular Surgery at George Washington University, “CorMatrix ECM for vascular repair is an innovative scaffold permitting the patient’s own stem cells to regenerate viable autogenous tissue improving the results of revascularisation procedures that often fail due to myointimal hyperplasia and accelerated atherosclerosis.”


“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 novel device to meet current clinical needs,” comments Andrew Green, CorMatrix Cardiovascular’s executive vice president of Operations. “Expansion of our current FDA-cleared devices to satisfy unmet indications further strengthens our leadership position in the field of ECM technologies and regenerative medicine, utilising the patient’s own stem cells and their natural healing ability.”