Medical device firm CorMatrix Cardiovascular has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Tkye implantable device, developed for neonate and infant cardiac tissue repair.
Tyke, which is a biomaterial technology derived from the firm’s ECM technology platform, was developed to repair pericardial structures in neonates and infants.
It can be used as an epicardial covering for damaged or repaired cardiac structures, as well 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 compared to four layers of the current CorMatrix ECM, providing thinner product for smaller repairs.
The firm has designed the product as an alternative to synthetic grafts or patches.
It also enables congenital cardiovascular surgeons to repair complex reconstructive surgeries in neonates and infants with congenital heart defects (CHD), including atrial-septal defects and small pulmonary vessels.
CorMatrix Cardiovascular CEO and co-founder David Camp said: "FDA clearance further validates CorMatrix ECM technology for creating world class implantable cardiac devices.
"CorMatrix is proud of this clearance achievement and the potential impact it can have on reducing CHD in children."
The firm will initially test the Tyke device in around 15 clinical sites, as part of the post-market study.
In the study, the company plans to include around 150 patients undergoing pediatric cardiovascular procedures.