CorMatrix Cardiovascular said today it launched its CorMatrix Tyke cardiac tissue repair patch designed for correcting congenital heart defects in neonates and infants, touting the 1st successful procedures utilizing the patch.
The CorMatrix Tyke is a patch designed to repair pericardial structures and as an epicardial covering or for intracardiac defects, septal defects, annulus repair, suture-line buttressing.
“We are excited to partner with our pediatric cardiac surgeons to deliver Tyke as product developed to address a specific need in the neonatal and infant population. CorMatrix Tyke is one of the few products commercially available that is specifically designed and labeled for the treatment of neonate and infant cardiac tissue repair,” CEO Andrew Green said in a prepared statement.
The Tyke patch features 2 layers of CorMatrix ECM, which the Roswell, Ga.-based company said is 2 layers less than its standard ECM patch, making it smaller and lighter for young patients.
CorMatrix said the patch 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 availability of Tyke and its 2 ply construction will allow us the ability to repair the tiniest structures in the most delicate and tiniest of newborn babies, and achieve a more accurate—and hopefully—more durable repair. We are excited about the future Tyke provides for our most fragile patients,” Dr. Frank Scholl of Hollywood, Fla.’s Joe DiMaggio’s Children’s Hospital, 1 of the 1st surgeons to implant the device, said in a prepared release.
CorMatrix said it is implementing a phased commercial launch of the device at approximately 20 pediatric centers, with training and certification provided.
The company won FDA 510(k) clearance for the Tyke biomaterial back in February.