DEFINITION

Scaffold Porcine Small Intestinal Submucosa is a collagen-based scaffold, translucent and off-white in color. It is obtained from the small intestinal submucosa layer of the domestic pig (Sus scrofa L.). This layer has been mechanically separated from the adjoining layers of the intestine to remove the serosal, mucosal, and muscular elements. The isolated submucosa is chemically cleaned, decellularized, freeze-dried, and terminally sterilized. Scaffold Porcine Small Intestinal Submucosa also undergoes a viral inactivation; the inactivation method is validated using parvovirus, reovirus, pseudorabies virus, and leukemia retrovirus as the test viruses. By dried weight, Scaffold Porcine Small Intestinal Submucosa consists of about 70% protein, about 20% carbohydrate, and about 7% lipid. The protein component is primarily collagen type I, with minor amounts of elastin and collagen type III, collagen type IV, and collagen type VI. In addition to these components, additional extracellular matrix components, such as glycosaminoglycans and fibroblast growth factor-2, are also retained.