CorMatrix uses Tyke to treat first patient with congenital heart defect

22 June 2016 (Last Updated June 22nd, 2016 18:30)

US-based CorMatrix Cardiovascular has treated the patient using its CorMatrix Tyke, which is designed to repair cardiac tissues in neonates and infants.

US-based CorMatrix Cardiovascular has treated the patient using its CorMatrix Tyke, which is designed to repair cardiac tissues in neonates and infants.

In February, the US Food and Drug Administration (FDA) granted 510(k) clearance for CorMatrix Tyke.

It can be applied on infants to repair pericardial structures, which acts as an epicardial covering for damaged or repaired cardiac structures.

The product acts similar to patch material for intracardiac defects, septal defects and annulus repair, suture-line buttressing, and cardiac repair.

"The availability of Tyke and its two ply construction will allow us the ability to repair the tiniest structures in the most delicate and tiniest of newborn babies."

Tyke is composed of two layers of CorMatrix ECM when compared to the existing CorMatrix ECM for Cardiac Tissue Repair with four layers.

The new product with its thinner texture is applicable for smaller repairs.

Pediatric and congenital heart surgery and surgical director, pediatric heart transplant chief Dr Frank Scholl said: "The availability of Tyke and its two 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."

According to the American Academy of Pediatrics and the Congenital Heart Public Health Consortium (CHPHC), congenital heart defects are most commonly occurring birth defects.

Approximately 40,000 babies are born with the congenital heart defect in the US.

CorMatrix president and CEO Andrew Green said: "CorMatrix Tyke is one of the few products commercially available that is specifically designed and labelled for the treatment of neonate and infant cardiac tissue repair."