Medical Device Daily Associate

The FDA has cleared Cook Biotech’s (West Lafayette, Indiana) Surgisis AFP fistula plug, which the company said is “the first and only surgical device for repair of fistulas.”

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 Surgisis AFP device is for anal rectal fistulas, the indication for which the FDA clearance was received.

Cook Biotech, a business of Cook (Bloomington, Indiana), was established in 1995 to develop products based on extracellular matrix (ECM) biomaterials. The Surgisis AFP device is based on this ECM technology.

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 no longer is needed and is absorbed by the body.

The Surgisis AFP, marketed 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 bio-scaffold to facilitate well-organized tissue regeneration to close the fistula.

Andy Cron, vice president of Cook Surgical, told Medical Device Daily that the company had heard that surgeons were using the biomaterial on an off-label basis to treat anal rectal fistulas. “We had some physicians that began to roll this up themselves, like a cigarette almost, and started putting them in fistulas because there were really no alternatives in a lot of these cases, and they started to inform us of success. So we’ve really just tried to take that to the next step and have a pre-formed plug that’s designed to increase the success of closure of these fistulas.”

“This uses Cook’s [porcine] small intestinal submucosa [SIS] biomaterial and basically they implant it and it non-surgically closes the fistula and encourages native tissues to re-grow,” company spokesperson David McCarty, told MDD.

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, the company noted, leaving the patient with a chronic, debilitating problem. More than 125,000 surgeries to repair fistulas are performed each year in the U.S.

With the Surgisis AFP, McCarty said, “you get a nice, clean closure of the fistula without having to perform surgery or use this fibrin glue which is only affective in about 40% of the cases.”

At the annual meeting of the American Society of Colorectal Surgeons (Arlington Heights, Illinois) in Philadelphia next month, David Armstrong, MD, program director of the Georgia Colon and Rectal Surgical Clinic (Atlanta), and his associates will present data from a clinical study that evaluated the efficacy of the Surgisis AFP device vs. fibrin glue in closing fistulas.

The study found an 87% fistula closure rate in the patient group treated with Surgisis AFP, while patients receiving fibrin glue had only a 40% fistula closure rate at three months.

“Surgisis AFP is easily placed, is tolerated well by patients and is showing significant improvement over conventional therapies,” said Armstrong, “It is a simple and innovative treatment for a condition which was a notoriously difficult and complex surgical problem.”

While the Surgisis device is currently only indicated for the treatment of anal rectal fistulas, Cron said that some iteration incorporating the biomaterial could be used for other fistulas, including rectovaginal fistulas and gastric fistulas.

He said that after the company hears about successful off-label uses of the material, it may decide to go forward with trials for these and other applications. “I think that what you’ll see is that we’ll file and try to get a broader use in some [of these] other fistulas.”

“The material is very versatile and works essentially anywhere in the body,” added McCarty, noting that the company also is using the SIS material to replace the dura mater – the tough, outermost, fibrous membrane that covers the brain and spinal cord, and lines the inner surface of the skull – that has to be cut or removed for neurosurgery. He said it also is being used for hernia repair, skin wound repair and diabetic ulcers.

“It’s a platform technology,” McCarty said, adding, “We’re looking at probably 70 or 80 other applications right now.”

The company originally acquired the SIS technology via a license from Purdue University (also West Lafayette), and has the rights to manufacture medical devices from the material in all areas except orthopedics.