The Food and Drug Administration (FDA) has granted 510(k) clearance to CorMatrix Cardiovascular to market its CorMatrix extracellular matrix (ECM) for carotid repair. The ECM technology provides a natural bio-scaffold enabling a patient’s own host cells to repopulate and repair damaged tissues.
The CorMatrix extracellular matrix technology is currently FDA cleared for pericardial closure and cardiac tissue repair. Its recent 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 peripheral vascular surgery community is quite familiar with the use of the CorMatrix technology by cardiac surgeons for pericardial reconstruction and cardiovascular repair. We are excited to have a unique CorMatrix material, with several potentially advantageous properties, now available for use in carotid endarterectomy,” said W Darrin Clouse, director, Northern California Federal Vascular Surgery, USA.
“We believe the unique properties of our CorMatrix material provide a new and vital alternative to current approaches in carotid artery repair. Having received numerous inquiries from the clinical surgery community for a CorMatrix product to address this clinical need, we were very pleased with the timely manner in which FDA reviewed and cleared this submission.” stated David Camp, chairman and CEO of CorMatrix.