CorMatrix Cardiovascular has announced FDA 510(k) approval for its Tyke extracellular matrix biomaterial for use in neonates and infants.
The company has created a patch that supports native tissue repair by providing an interim bioscaffold, which enables a patient’s own cells to repopulate and repair damaged tissues. CorMatrix technology thus far has been used at more than 825 hospitals across the U.S. and has been implanted in over 130,000 cardiac procedures.
The Tyke was developed as an alternative to synthetic grafts and patches to improve the repairing of complex reocnstructive surgeries in young patients with congenital heart defects such as atrial-septal defects and small pulmonary vessels. The patch was derived from the company’s extracellular matrix, or ECM technology platform, and is composed of 2 layers of ECM, as opposed to 4 layers in their standard cardiac tissue repair patches, making it thinner for smaller repairs.
After this approval the CorMatrix Tyke will be available early at 15 clinical sites taking part in a post-market study, which aims to enroll up to 150 patients undergoing pediatric cardiovascular procedures.