Surgery
FDA Gives Clearance to Surgisis® AFP™ Fistula Plug as the First Device for Repair of Fistulas
By Cook, Inc.
Apr 29, 2005, 10:13

The U.S. Food and Drug Administration has cleared the Surgisis® AFP™ Fistula Plug as the first and only surgical device for repair of fistulas, Cook Biotech Incorporated announced today.

A fistula is an abnormal channel that develops between body organs. The most common fistulas occur from the intestine to an opening in the skin. The presence of a fistula can be painful and seriously impact a patient’s quality of life. Unfortunately, current treatments involving either an extensive surgical procedure or use of fibrin glue do not always yield satisfactory results, leaving the patient with a chronic, debilitating problem. More than 125,000 surgeries to repair fistulas are performed each year in the United States.

Surgisis AFP, sold by Cook Incorporated’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 bio-scaffold to facilitate well-organized tissue regeneration to close the fistula.

At the annual meeting of the American Society of Colorectal Surgeons in Philadelphia next month, Eric Johnson, M.D., Janette Gaw, M.D., and David Armstrong M.D., will present data from a clinical study that evaluated the efficacy of the Surgisis AFP device versus fibrin glue in closing fistulas. The study found an 87 percent fistula closure rate in the patient group treated with Surgisis AFP, while patients receiving fibrin glue had only a 40 percent fistula closure rate at three months.

"Surgisis AFP is easily placed, is tolerated well by patients and is showing significant improvement over conventional therapies,” explained Dr. David Armstrong, Program Director of the Georgia Colon and Rectal Surgical Clinic in Atlanta, Georgia. “Surgisis AFP is a new paradigm in the treatment of fistulas. It is a simple and innovative treatment for a condition which was a notoriously difficult and complex surgical problem.”

Surgisis AFP is based on Cook Biotech’s innovative extracellular matrix (ECM) 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.

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