The first patients have been treated using CorMatrix Tyke, a product specifically designed and cleared for cardiac tissue repairs in neonates and infants, according to CorMatrix Cardiovascular Inc., a developer of biomaterials and medical devices. The product received FDA 510(k) clearance in February.
Tyke is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defects and annulus repair, suture-line buttressing, and cardiac repair.
The product is made of two layers of CorMatrix ECM as compared to the four layers of the current ECM for cardiac tissue repair, providing a thinner product for smaller repairs.
The company is implementing a phased commercial launch of the device involving approximately 20 pediatric centers that will receive training and certification for the device. Tyke was developed as an alternative to synthetic grafts or patches, and for complex reconstructive surgeries in neonates and infants with congenital heart defects.
Surgeons Drs. Frank Scholl and Steven Bibevski, both at Joe DiMaggio Children’s Hospital in Hollywood, FL, were the first to implant the Tyke ECM device.
“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,” Scholl noted. “We are excited about the future Tyke provides for our most fragile patients.”
The American Academy of Pediatrics and the Congenital Heart Public Health Consortium estimates congenital heart defects are the most common birth defects. Nearly one of every 100 babies is born with a congenital heart defect and each year, approximately 40,000 of those babies are born in the United States.
Most surgical procedures involved require the use of prosthetic material for reconstruction of intracardiac and extra cardiac structures. Several different biological and prosthetic materials are commonly used in surgery including autologous pericardium, preserved homograft, bovine pericardium, and polytetrafluoroethylene.
CorMatrix noted that none of those alternatives represents the ideal prosthetic tissue, which should be pliable and easy to handle, resistant to calcification or shrinkage. It should have growth potential and should not induce formation of scar tissue, according to Scholl.