Feasibility Study of the Magnetic Anal Sphincter (FENIX System)

An Observational Clinical Feasibility Study of The Magnetic Anal Sphincter

The purpose of this feasibility study is to obtain preliminary safety and effectiveness information and develop procedural optimization for the Magnetic Anal Sphincter device (FENIX System) in reinforcement of anal sphincter function to treat severe fecal incontinence (FI).

Study subjects followed to 12 months post implant outside the U.S. Study subjects followed to 5 years post implant in the U.S.

Inclusion Criteria:

• Age ≥ 19 years, <85 years, life expectancy >3yrs.
• Documented history of severe fecal incontinence for at least 6 months
• Subject diary documents ≥ 2 episodes per week on average over diary period, leakage greater than seepage
• Subject has failed standard conservative and medical therapy
• Subject is a surgical candidate.
• Subject is willing and able to cooperate with follow-up examinations.
• Subject has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes.

Exclusion Criteria:

• Subject has history of significant obstructed defecation or other significant chronic defecatory motility disorders
• Subject has current, external full thickness rectal prolapse or vaginal prolapse
• Subject has an electric or metallic implant within 10cm of the area of device placement
• Subject has Inflammatory Bowel Disease
• Subject has Irritable Bowel Syndrome
• Subject has systemic disease as source of FI (scleroderma, neurologic disorders, Crohn's)
• Subject has active pelvic infection
• Subject has chronic diarrhea
• Subject diagnosed with anal, rectal, or colon cancer within 2 years
• Subject has had prior anterior resection of the rectum
• Subject has undergone pelvic radiation therapy
• Subject has significant scarring of the recto-vaginal septum, a permanent implant in the recto-vaginal septum, or a history of recto-vaginal fistula
• Subject has had previous anorectal posterior compartment surgery
• The procedure is an emergency procedure
• Subject is currently being treated with another investigational drug or investigational device.
• Subject cannot understand trial requirements or is unable to comply with follow-up schedule.
• Subject is pregnant or nursing, or plans to become pregnant.
• Subject has history of complex anal fistula