Approximately 90,000 anal fistula procedures are performed in the US each year. People suffering from anal fistulas are generally between 18-50 years old, with men more commonly afflicted than women. The symptoms usually begin with a painful perirectal abscess that drains itself to the buttocks or requires a surgery for drainage. The result is the formation of the fistula tract through the sphincter complex out to the perianal skin. These symptoms include foul smelling drainage, pain and discomfort.
The treatment of anal fistulas is complex and there is no current gold standard treatment. Multiple surgical procedures have been developed with the intent to close and heal the fistula, prevent recurrence and preserve continence. These procedures include performing an endoanal flap to cover the internal opening, a LIFT procedure which ligates the fistula tract, insertion of cutting setons, fistulectomy and fistulotomy. Most of these procedures require extensive dissection which can lead to injury of the sphincter muscles causing incontinence and often require 2-4 follow up surgeries due to failed healing with recurrence. Other technologies were developed to occlude the fistula tract, using plugs or fibrin glues. Although these devices did not require tissue dissection, the outcomes were poor, leading to device migration, infection and recurrence.
Mechanism: Tissue apposition closure
BioHealx Assisted Fistula Treatment
BAFT
No dissection.
No damage to sphincter.
Negligible risk of incontinence.
Efficient & Accurate implant delivery. Excellent healing – 84.4%
Mechanism: Patch internal opening or divide the fistula tract / sphincter
Endoanal flap, LIFT, Fistulotomy with sphincter repair, cutting secton
Extensive dissection.
Potential damage to sphincter.
Predictable risk of incontinence.
Technically challenging.
20 – 40% failure rate.
Mechanism: Fistula ablation, Internal filling of fistula tract
Laser ablation, plugs, glue
Extensive dissection.
Potential damage to sphincter.
Extensive dissection.
Potential damage to sphincter.
Extensive dissection.
Potential damage to sphincter.
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