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 3 months * 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.