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Cook Biotech, Inc.

FDA clears Surgisis AFP Fistula Plug for fistula repair

Published in FDA Law Weekly, May 26th, 2005

The U.S. Food and Drug Administration (FDA) has cleared the Surgisis AFP Fistula Plug as the first and, according to its maker, only surgical device for repair of fistulas, Cook Biotech, Inc., announced.

Surgisis AFP, sold by Cook, Inc.'s surgical division, is a cone-shaped medical device that has been specifically designed to allow a surgeon to 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.

At the recent annual meeting of the American Society of Colorectal Surgeons in Philadelphia, Pennsylvania, Eric Johnson, MD, Janette Gaw, MD, and David...

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