DEFINITION

Scaffold Bovine Dermis is a remodelable collagen scaffold derived from fetal or neonatal bovine skin. It is presented to the physician as a flat white sheet that is cut to size and hydrated in room-temperature sterile saline solution before implantation. The sterile material is surgically secured, onlayed, and/or packed into deficient soft tissues such as skin, tendon, muscle, and dura mater. In order to provide antimicrobial protection of the Scaffold Bovine Dermis, silver nitrate solution may be added to the Scaffold Bovine Dermis, resulting in ionic silver as a component. The source fetal or neonatal bovine skin is mechanically and chemically processed to isolate the dermis and remove cells and cellular components. To prevent the transmission of infectious disease, the manufacturing process has been validated to inactivate viruses potentially present in the source material. To prevent the spread of transmissible spongiform encephalopathies, the source material is acquired from appropriate geographic locations in accordance with relevant guidelines subject to governmental oversight. The product is inspected and tested to ensure that the product meets specifications.