Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas

Inclusion Criteria

• Male and female subjects at least 18 years of age.
• Provide informed consent
• Non-pregnant females
• Clinical diagnosis of 1 high transsphincteric anorectal fistula, with 1 internal opening and 1-2 external openings, with a single seton in place.
• Seton placement for a minimum of four (4) weeks
• Willingness to participate in post-operative follow-up evaluations.

Exclusion Criteria

• Inability to provide informed consent.
• Medical history of Crohn's disease/Ulcerative Colitis.
• Subjects with multiple fistula tracts (defined as >1 internal opening and/or >2 external openings), secondary tracts, horseshoe fistulas, J-pouch fistulas, superficial fistulas, ano/recto-vaginal fistulas or rectourethral fistulas.
• Previous fistulotomy/fistulectomy at the target treatment site (a history of these procedures at other locations is not exclusionary).
• Fistula of traumatic origin including obstetric.
• Evidence of ongoing local infection.
• Evidence of active abscess at the time of treatment.
• Chronic disease such as congestive heart failure, liver disease, renal disease, insulin dependent diabetes (as determined by A1C reading from past 6-12 months), or any chronic illness that may interfere with participation in this study.
• Active and unstable disease state or infection anywhere in the body per Investigator's evaluation and determination.
• Autoimmune disease that is not stable.
• Subjects who are immunocompromised such as known human immunodeficiency virus (HIV) or currently receiving chemotherapy or radiation therapy.
• Ongoing use of antiplatelet drugs. Subjects may be included in the study if antiplatelet drugs have been stopped for 5 to 7 days prior to surgery.
• Known coagulopathy (demonstrated by stated or medical record history of diagnosis)
• Pregnancy
• Previous history of radiation therapy in the area of the fistula.
• History of collagen disease.
• Known allergy to porcine products.
• Religious objection to use of porcine products.