The Signum Surgical BioHealx implant is a helical, barbed absorbable implant that is placed around the outside of the fistula tract, compressing the tissue edges together, closing it across the width of sphincter muscle. The implant is placed using a pre-loaded, single-use, disposable delivery device that rotates the helical implant into the soft tissue surrounding the fistula tract at its source within the sphincter muscle. Post delivery, the device is fully enclosed in tissue and is not exposed to the ano-rectal canal.
If you’re frustrated by prolonged healing, risk of incontinence, and high recurrence rates, you’re not alone. At Signum Surgical, we believe patients deserve better. That’s why we’ve developed a solution designed to optimize the procedure, promote healing, and prevent recurrence.
Patients endure a poor quality of life, experiencing pain, suffering and discharge from the tract and related abscesses.
Current treatment options have poor results, with the risk of causing permanent incontinence, inadequate healing, & repeat surgeries.
There are 90,000 annual surgical procedures performed to treat anal fistula in the U.S. alone.
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