KSEF RDE: Drug Eluting Biodegradable Seton for Treatment of Perianal Fistulas in Crohn's Disease

Crohn's disease is an inflammatory bowel disease that results from a dysregulated immune response to the commensal intestinal flora. As a result, perianal manifestations occur and, in particular, fistulas represent a therapeutic challenge. The cumulative frequency of perianal fistulas in patients with Crohn's disease has been reported to range from 14% to 38 % in referral centers (1), with 17% to 28 % of patients requiring surgery for Crohn's disease. Current treatment of fistulas results in less then 30% long term remission and is accompanied by significant side-effects. We aim to develop a biodegradable surgical drain (Seton) that releases an antiinflammatory drug in a controlled fashion. We hypothesize that our product will allow uniform healing throughout the fistulous tract while allowing effective drainage. Due to their excellent properties, administration of drugs using biodegradable PLGA has been widely applied and studied. Besides its ease of formulation as a drug carrying device, it also has been approved by the FDA. PLGA degradation rate in any form of devices can be tailored using its dependency on the physical properties, such as ratio, molecular weight, and polydispersity index. The unique features of our device will significantly impact fistula recurrence. On the other hand, the biodegradable nature of the Seton, will address the patient discomfort and fistula persistence associated with non-resorbable drains. By virtue of low surface of contact and dose released, this product can significantly improve the safety profile of the released drug.