Ligation of the Intersphincteric Fistula Tract (LIFT) + Biodesign for Anal Fistula

Ligation of the Intersphincteric Fistula Tract With Tissue Graft Placement for Treatment of Persistent Trans-sphincteric Anal Fistula

The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of fistula closure in patients with persistent trans-sphincteric anal fistula who receive the Biodesign® Tissue graft as part of their LIFT procedure.

Inclusion Criteria:

• Persistent primary or recurrent trans-sphincteric anal fistula

Exclusion Criteria:

• Patients with prior fistulotomy, fistulectomy, LIFT, cutting seton or advancement flap procedure
• Fistula with multiple tracts
• Recto-vaginal fistula
• Active infection in the anal fistula
• Physical allergies or cultural objections to porcine products
• Patient is not medically fit to undergo the LIFT procedure as judged by the treating physician
• Previous diagnosis of collagen disorder
• History of Crohn's Disease, Irritable Bowel Syndrome, radiation therapy in the rectoanal region