The US Food and Drug Administration (FDA) has granted 510(k) clearance for medical device firm CorMatrix Cardiovascular’s Tkye implantable device, developed for neonate and infant cardiac tissue repair.
Tyke is a biomaterial technology based on the firm’s ECM platform, and was developed to repair pericardial structures in neonates and infants.
The device can be used 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 compared to four layers of the existing CorMatrix ECM, providing thinner product for smaller repairs.
The company has designed the product as an alternative to synthetic grafts or patches.
The device also allows 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 scientific director Dr Robert Matheny said: "The Tyke product was developed in response to congenital surgeon’s directed needs. It is our stated goal to continue to develop the cardiovascular regenerative products as dictated by the needs of patients and physicians.
"One size doesn’t fit all applications and the Tyke is a step in the direction of satisfying a particular surgical need. We are currently in clinical trials to apply the technology to congestive heart failure and heart valves."
Congenital heart defects are believed to be the most common birth defect, according to the American Academy of Pediatrics and the Congenital Heart Public Health Consortium (CHPHC).
The company develops biomaterials that harness the body’s ability to repair damaged cardiac and vascular tissues.
As part of the post-market study, the company will initially test the Tyke device in around 15 clinical sites across the US.
In the study, the company plans to include around 150 patients undergoing pediatric cardiovascular procedures.
They will be enrolled at the time of treatment and monitored at standard follow-up time points with routine collection of data.
Based upon early collection of patient data, the company will schedule the commercial availability of the product and expansion it to additional centres under normal launch conditions.