Carotid Tissue Repair Device Gets 510(k) Nod from FDA

CorMatrix (Atlanta, GA) has announced that the FDA has given its ECM extracellular matrix 510(k) clearance for carotid repair, permitting its use for patch closure following endarterectomy and suture-line buttressing. The material, which helps induce the body’s natural ability to repair damaged cardiovascular tissue, was previously approved by the FDA for cardiac tissue repair and pericardial closure applications.

Made of porcine small intestinal submucosa, CorMatrix ECM is a cellular bioscaffold that has been used in more than 500 hospitals in the United States and has been implanted in more than 40,000 patients.

Check out the press release for more background information on the product:

The unique properties of extracellular matrix biomaterials were discovered at Purdue University. The decellularized matrix material serves as a scaffold to allow adjacent tissues to deliver cells and nutrients to the matrix, which then differentiate into tissue-specific cells. The CorMatrix implant is gradually replaced, as the patient’s own body reinforces and rebuilds the weakened site. During the repair, the matrix is naturally degraded and resorbed, leaving remodeled functional tissue where scar tissue or injured tissue would normally be expected.

The use of extracellular matrix materials in non-cardiovascular applications has established a significant foothold in soft tissue repair, wound management and orthopedic applications. The safety of extracellular matrices has been well established in a number of different clinical applications. The extracellular matrix has been studied extensively, with more than 500 published papers. Since 1999, over a million patients worldwide have received an extracellular matrix implant.

Last year, The Heart Surgery Forum published a study analyzing the use of the ECM material to reconstruct the pericardium in patients undergoing primary isolated coronary artery bypass grafting. The study reported that the material contributed to a clinically meaningful reduction in the rate of new onset postoperative atrial fibrillation.

Press release: CorMatrix Receives Carotid Artery Repair Indication for its CorMatrix® ECM®

Flashbacks: CorMatrix’s Cardiac Tissue Repair Gets CE Mark; Novel Surgical Biomaterial Receives Regulatory Approvals