CorMatrix Cardiovascular said today it won FDA 510(k) clearance for its Tyke biomaterial for use in neonates and infants.
The patch is designed to repair pericardial structures and as an epicardial covering or for intracardiac defects, septal defects, annulus repair, suture-line buttressing.
The Tyke is derived from the company’s ECM technology platform and is composed of 2 layers of ECM, as opposed to 4 layers in their standard cardiac tissue repair patches, making it thinner for smaller repairs.
“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. This is but one small step in our ongoing quest to develop and deliver ideal materials for use in reconstructing damaged cardiac and vascular tissues. Tyke and other CorMatrix cardiac products will help us extend and improve the lives of those who receive our implants and move toward a global goal of making cardiovascular disease curable,” CEO David Camp said in a press release.
The Tyke was developed as an alternative to synthetic grafts and patches to improve the repairing of complex reocnstructive surgeries in young patients with congenital heart defects such as atrial-septal defects and small pulmonary vessels, the company 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,” scientific director Dr. Robert Matheny said in prepared remarks.
The CorMatrix Tyke will be available early at 15 clinical sites taking part in a post-market study, which aims to enroll up to 150 patients undergoing pediatric cardiovascular procedures. The company plans to schedule a larger release based on early collection of patient data.
“CorMatrix ECM has been useful in repairing children’s hearts but there were a few areas where a thinner material would even be better. This is why we are excited about the Tyke—we now have an option to perhaps repair even the smallest structures more accurately,” Dr. David Morales of Ohio’s Cincinnati Children’s Hospital Medical Center said in a prepared statement.