Anal fistula care is changing. This article explains what is new, why change was needed, and the importance of a sphincter-sparing approach.
What’s new in anal fistula treatment?
New treatments in anal fistula aim to improve healing while reducing the need for additional procedures and reducing the risk of incontinence. BioHealx® is a new treatment for anal fistula, having been FDA De Novo-authorized in July 2024. BioHealx offers a minimally invasive approach to primary fistula healing, without compromising the anal sphincter.
Why is innovation in anal fistula care needed?
Anal fistula has long been a challenging condition to treat, creating an ongoing need for innovation in anal fistula care. Because a fistula can pass through or near the sphincter muscles, its path complicates treatment. Both patients and surgeons continue to seek new treatment options that address the limitations of existing approaches and improve outcomes.
What challenges remain with current surgical options?
Current surgical options include endoanal flap, LIFT, fistulotomy, cutting seton and laser (FiLaC). Many options are associated with a risk of incontinence and high recurrence rates.1,2
For results reported for these procedures, see published outcomes from traditional surgical procedures.
Your healthcare provider can answer questions and help you choose the treatment that’s best for you.
What is a minimally invasive, sphincter-sparing approach to anal fistula surgery?
BioHealx Assisted Fistula Treatment (BAFT™) is minimally invasive and sphincter-sparing because no dissection is required within the sphincter complex and minimal sphincter muscle is incorporated into the closure.3
Learn more about how BioHealx works.
Where can I read the clinical evidence?
Published outcomes for different types of anal fistula procedures are widely available. Some key relevant journal articles are available in our published outcomes article.
Clinical trial results for BioHealx® were published in a peer-reviewed journal article, showing 84.4% fistula healing and 96.8% stable or improved continence.3 More information on the clinical study can be found in the BioHealx clinical study results.
Signum Surgical is focused on innovation in anal fistula care. Read more about the company and its mission.
We’ve developed the BioHealx solution to optimize the procedure, promote fistula healing, and prevent recurrence.
For more patient resources, visit our Education page.
References
1 Aguilar-Martínez MDM, et al. Dis Colon Rectum. 2021 Nov 1;64(11):1374-1384.
2 Ergüder et al. Outcome of transanal advancement flap repair (TAFR) after failed LIFT. Colorectal Disease. 2025;27:e70199.
3 Harsányi et al. The novel BioHealx®-assisted fistula treatment (BAFT): effective primary fistula healing with continence preservation. International Journal of Colorectal Disease. 2025;40:110.