A new technology for patients with anal fistula

Anal fistula is a painful colorectal condition that affects hundreds of thousands of people worldwide ¹

Dissatisfied with current treatments

An anal fistula is an artificial tunnel between the rectum and skin of the buttocks that can develop due to an infected or blocked anal gland. If left untreated, an abscess may form, and the infection may travel through the patient’s sphincter muscle. Patients and their physicians are dissatisfied with current treatment options, which frequently result in inadequate or slow healing, a high risk of fecal incontinence, and repeat procedures.

QUALITY OF LIFE

Patients endure a poor quality of life, experiencing pain, suffering and discharge from the tract and related abscesses.

NO EFFECTIVE CURE

Patients and their physicians are dissatisfied with current treatment options, which are not effective for curing anal fistula.

SUCCESS RATES

Current treatment options have poor results, with the risk of causing permanent incontinence, inadequate healing, and repeat surgeries.

THE NUMBERS

There are 90,000 annual surgical procedures performed to treat anal fistula in the U.S. alone.²

The Solution

The Signum Surgical BioHealx™ implant is a helical, barbed bioabsorbable implant that is placed to close an anal fistula at the internal opening by tissue apposition. The implant is placed using a pre-loaded, single-use, disposable delivery device that rotates the helical implant into the soft tissue surrounding the internal opening of fistula. Post delivery, the device is fully enclosed in tissue and is not exposed to the ano-rectal canal.

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1. Ommer A et al: Clinical practice guideline: Cryptoglandular anal fistula. Dtsch Arztebl Int 2011; 108(42): 707–13. 2. Zanotti, C., Martinez-Puente, C., Pascual, I. et al. Int J Colorectal Dis (2007) 22: 1459