Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair

Primary outcome variable is healing at the final follow up visit.

Inclusion Criteria:

- Transsphincteric fistula consisting of 1 tract(defined as a fistula which would not
be amenable to fistulotomy); determined during operative procedure

- Likely cryptoglandular origin

- Must be at least 18 years of age

- Patients informed about the study, and will have read, understood and signed the
patient informed consent and authorization to use PHI data, as applicable

- Patients willing and able to submit to postoperative follow-up evaluations

Exclusion Criteria:

- Crohn's Disease

- Evidence of on-going local infection

- History of more than 2 prior definitive repair attempts; repair attempt is defined as
any of the following: advancement flap, cutting seton, fistulotomy, fistulectomy,
fibrin glue, anal fistula plug, LIFT

- Superficial fistulas without any muscle involvement

- Fistulae of traumatic origin, including obstetric

- Intersphincteric fistulas that would be candidate for fistulotomy

- Horseshoe or multi-tract fistulas

- Ano-vaginal or recto-vaginal fistulas

- Anastomotic fistulas (ileo-anal, colo-anal)

- A wound-healing or autoimmune disorder (including insulin-dependent diabetics)

- Subjects who are immunocompromised such as, with HIV, or currently receiving chemo or
radiation therapy

- Subjects who are immunosuppressed, e.g. transplant patients, patients taking
steroids, TNF agents, methotrexate

- History of prior or current pelvic radiation

- Difficulty comprehending or complying with the study (in surgeon's opinion)