Bryn Mawr, PA — A Main Line Health team has become the first in Pennsylvania to implant a new, cutting-edge device for a challenging condition that causes a painful, sometimes debilitating condition in the rectal area and has long frustrated colorectal surgeons.
Anal fistula is a common affliction characterized by an abnormal passageway that forms from the inside of the anus to the skin outside. Treatment can result in slow healing, often requires repeat procedures and comes with the risk of incontinence.
Philip Pearson, MD, and his surgical team at Bryn Mawr Hospital recently became the first in the state, and among the first nationally, to implant the BioHealx® device. The surgery was done with a quick, minimally invasive procedure.
“Anal fistula is a common disease that no one talks about and is difficult to fix,” said Dr. Pearson, who has been treating patients for nearly 30 years. “We’ve used a gel, a plug and a flap of tissue, but outcomes frequently are unsuccessful. By far, this is the best solution that we’ve ever had to offer. I’m excited about starting to use it for our patients.”
BioHealx is a spiral, barbed absorbable implant that is placed around the fistula tract to close it within the sphincter muscle by bringing tissue edges together. The implant is placed using a preloaded, single-use, disposable delivery device that rotates the implant into the soft tissue surrounding the fistula tract at its source within the sphincter muscle. Once implanted, the device is fully enclosed in tissue and is not exposed to the anorectal canal. The BioHealx device fully absorbs in six to 12 months.
Anal fistulas affect one in 5,000 people worldwide. In the United States, over 90,000 surgeries are performed annually to treat the condition.
Signum Surgical was granted marketing clearance by the U.S. Food and Drug Administration for the first-of-its-kind medical device in July 2024.
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