BioHealx® Anal Fistula Device Post Market Surveillance Study

Inclusion Criteria:

* Age 18 - 75 years
* Presence of Single Continuous Anal Fistula presenting for initial curative surgery
* Failed or Recurrent Anal Fistula Closure
* Minimum of 6-weeks of draining seton placed prior to procedure.
* Availability for follow-up contacts and willingness to complete the Informed Consent.

Exclusion Criteria:

* Fistula tract shorter than 2cm
* Complex fistula tract (branching)
* Body Mass Index \> 35
* Known uncontrolled diabetes or other systemic condition associated with impaired healing
* Known HIV-positive or immunocompromised
* Rectal prolapse
* Pregnancy
* Rectal / fistula malignancy
* Crohn's disease
* Ulcerative proctitis
* Hidradenitis suppurativa of the anal region
* Pilonidal sinus disease
* Presence of hemorrhoid Involving fistula site
* Continuous use of anti-inflammatory
* Intersphincteric fistula in ano or fistula treatable by simple fistulotomy
* Active infection or abscess involving fistula site
* Known allergy to PLGA material
* Any severe acute or uncontrolled chronic disease that according to the investigator might render the patient unsuitable for the study
* Treatment with an investigational drug or medical device in the past 30 days