The first patients have been treated using CorMatrix Cardiovascular’s Tyke.
The product received US Food and Drug Administration 510(k) clearance in February 2016. It 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.
Tyke is made of two layers of CorMatrix ECM as compared to the four layers of the current CorMatrix ECM for cardiac tissue repair, therefore providing a thinner product for smaller repairs.
Frank Scholl, chief, Pediatric & Congenital Heart Surgery and surgical director, Pediatric Heart Transplant and Steven Bibevski, ediatric & congenital cardiac surgeon, both at Joe DiMaggio Children’s Hospital in Hollywood, USA, were the first to implant the CorMatrix Tyke ECM device.
The company is implementing a phased commercial launch of the device involving approximately 20 paediatric centres who will be trained and certified to receive the device.
According to a company release, Tyke was developed as an alternative to synthetic grafts or patches, and for complex reconstructive surgeries in neonates and infants with congenital heart defects (CHD).
Scholl noted, “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.”