BioHealx® Anal Fistula Device Post Market Surveillance Study

BioHealx® Anal Fistula Device Post Market Surveillance Study

This post market surveillance study is a single arm multicenter study to demonstrate the long-term durability and effectiveness of the BioHealx Anal Fistula Device for fistula-in-ano closure (internal and external fistula openings).

Inclusion Criteria:

• Age 18 - 75 years
• Presence of Single Continuous Anal Fistula presenting for initial curative surgery
• Failed or Recurrent Anal Fistula Closure
• Minimum of 6-weeks of draining seton placed prior to procedure.
• Availability for follow-up contacts and willingness to complete the Informed Consent.

Exclusion Criteria:

• Fistula tract shorter than 2cm
• Complex fistula tract (branching)
• Body Mass Index > 35
• Known uncontrolled diabetes or other systemic condition associated with impaired healing
• Known HIV-positive or immunocompromised
• Rectal prolapse
• Pregnancy
• Rectal / fistula malignancy
• Crohn's disease
• Ulcerative proctitis
• Hidradenitis suppurativa of the anal region
• Pilonidal sinus disease
• Presence of hemorrhoid Involving fistula site
• Continuous use of anti-inflammatory
• Intersphincteric fistula in ano or fistula treatable by simple fistulotomy
• Active infection or abscess involving fistula site
• Known allergy to PLGA material
• Any severe acute or uncontrolled chronic disease that according to the investigator might render the patient unsuitable for the study
• Treatment with an investigational drug or medical device in the past 30 days