Where do SIS products come from?

Origin

SIS tissue repair products are biologic grafts created from porcine small intestinal submucosa (SIS). The submucosa is located between the mucosal and muscular layers of the small intestine. The submucosal layer provides strength to the small intestine through a complex organization of collagen that forms a fibrous matrix. SIS material is obtained from the intestine in a manner that removes all cells, but leaves the naturally fibrous and porous nature of the matrix. The careful processing leaves the complex extracellular matrix available for new cell ingrowth.

Composition

The thin, yet strong layer of the small intestine from which SIS products are derived possesses a 3-dimensional architecture that allows for intimate cell contact and consists primarily of protein. SIS products are manufactured using a unique process that minimizes the loss of the natural extracellular matrix components.

Safety and Biocompatibility

To assure patient safety, the SIS material undergoes a thorough disinfection, decellularization, and viral inactivation process. As a final step in the process, all SIS products are sterilized by validated sterilization methods.

SIS products have been rigorously tested to confirm that they are biocompatible.

In vitro test results demonstrate that the human complement cascade is not activated following exposure to SIS products, indicating that they do not elicit an acute rejection response.

Overall, numerous steps have been taken to ensure the safety of SIS products. These include:

• Strict control of source animals.
• Certified animal production facilities.
• Use of a validated disinfection process.
• Complete sterilization.
• Independent laboratory testing to verify biocompatibility.