New carotid tissue repair device nets 510(k) clearance

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CorMatrix Cardiovascular, which develops extracellular matrix (ECM) biomaterial devices for cardiovascular tissue repair, has received FDA 510(k) clearance to market its CorMatrix ECM for carotid repair.

The Atlanta-based company said the ECM technology platform, which provides a natural bio-scaffold enabling a patient's own host cells to repopulate and repair damaged tissues, is currently FDA cleared for pericardial closure and cardiac tissue repair. This 510(k) clearance adds to the CorMatrix product line with a new design and indication for vascular reconstruction and repair of the carotid artery, including patch closure following endarterectomy and suture line buttressing.