CorMatrix Cardiovascular receives 510(k) clearance for the Tyke implantable device for neonate and infant cardiac tissue repair

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CorMatrix Cardiovascular has received 510(k) clearance from the US Food and Drug Administration (FDA) for its CorMatrix Tyke, a biomaterial technology derived from the company’s extracellular matrix biomaterial (ECM) technology platform.

CorMatrix 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. Tyke is made of two layers of CorMatrix ECM as compared to the four layers of the current CorMatrix ECM for Cardiac Tissue Repair and therefore providing a thinner product for smaller repairs. Tyke was developed as an alternative to synthetic grafts or patches and to enable congenital cardiovascular surgeons to repair complex reconstructive surgeries, in neonates and infants with congenital heart defects (CHD), such as atrial-septal defects and small pulmonary vessels.

Several different biological and prosthetic materials are commonly used in surgery for CHDs, including autologous pericardium, preserved homograft, bovine pericardium, and polytetrafluoroethylene. None of these above-mentioned represents the ideal prosthetic tissue, according to a CorMatrix press release, which should be pliable and easy to handle, resistant to calcification or shrinkage, and, most importantly, should have growth potential and should not induce formation of scar tissue.

Robert Matheny, CorMatrix scientific director says, “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 does not 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.”

David Morales, director of Congenital Heart Surgery, The Heart Institute, Cincinnati Children’s Hospital Medical Center notes, “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.”

Early availability of CorMatrix Tyke will begin with up to 15 clinical sites across the USA that will take part in a post-market study. The study is targeted to include up to 150 patients undergoing paediatric cardiovascular procedures. Patients 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, broadened commercial availability will be scheduled, and expansion of the product extended to additional centres under normal launch conditions, according to a company release.