New carotid tissue repair device nets 510(k) clearance
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.
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.