CorMatrix wins FDA nod for Tyke neonate cardiac tissue

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 go...
Source: Mass Device - Category: Medical Equipment Authors: Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Regenerative Medicine Regulatory/Clearance CorMatrix Cardiovascular Inc. Source Type: news