CorMatrix Cardiovascular has received 510(k) clearance from the FDA for its CorMatrix extracellular matrix (ECM) for cardiac tissue repair, which utilizes the company’s proprietary ECM technology.
The company said its platform ECM technology provides a natural bioscaffold that allows a patient’s own host cells to repopulate and repair damaged tissues. The CorMatrix ECM is currently FDA-cleared for the reconstruction and repair of the pericardium.
Following implantation by a surgeon, CorMatrix said its ECM Technology products act as a scaffold into which the patient’s own cells migrate and integrate, stimulating the body’s innate wound-healing mechanisms to repair tissue at the site of implantation.
The additional indication expands the use of the implant to include suture-line reinforcing, buttressing for soft tissue reaproximation, repair of cannulation sites and bleeding sites, and as an intracardiac patch or pledget for tissue repair of structural problems such as septal defects, according to CorMatrix.