FDA Clears Cook's Surgisis AFP Fistula Plug

The FDA has cleared the Surgisis AFP Fistula Plug as the first and only surgical device for repair of fistulas, the company said.

Surgisis AFP, sold by Cook's surgical division, is a cone-shaped medical device that has been specifically designed to allow a surgeon to easily place it into a fistula channel. Once in place, Surgisis AFP serves as a bioscaffold to facilitate well-organized tissue regeneration to close the fistula -- an abnormal channel that develops between body organs.

The device is based on Cook Biotech's innovative extracellular matrix technology, a family of natural biomaterials that provides a rich environment for cell attachment and growth. Over time, the Surgisis biomaterial takes on the cellular characteristics of surrounding tissue while it serves as a scaffold on which human tissue grows. As the biomaterial is replaced with cells, the scaffold is no longer needed and it is absorbed by the body.