BioHealx® Anal Fistula Device Post Market Surveillance Study

This post market surveillance study is a single arm multicenter study to demonstrate the long-term durability and effectiveness of the BioHealx Anal Fistula Device for fistula-in-ano closure (internal and external fistula openings).

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