FDA Approves Fecal Incontinence Treatment Device

Miriam E. Tucker

Disclosures

December 18, 2015

The US Food and Drug Administration (FDA) has approved a device for restoring fecal continence in patients for whom other surgical or medical treatments are not possible or have not worked.

The Fenix Continence Restoration System (Torax Medical Inc.) is a small, flexible band of interlinked titanium beads with magnetic cores. The magnetic attraction between the beads within the anal sphincter creates a barrier to involuntary passage of fecal matter. For voluntary passage of stool, the magnetic bond is temporarily broken and then immediately restored.

The system is placed around the anal sphincter via a single-incision surgical procedure. An introducer tool is used to guide the implant into position, and a sizing tool is used to ensure the correct size. Once the device is implanted and secured with sutures, the correct size is confirmed using fluoroscopy.

"Non-invasive treatment options for fecal incontinence, such as drugs, dietary changes and other medical measures, sometimes don't adequately address a patient's symptoms," said William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, in an FDA release. "The Fenix System affords a viable surgical option to address this condition when other methods have failed to improve a patient's quality of life."

The device was approved through FDA's humanitarian device exemption process, used for devices intended to treat or diagnose conditions that affect fewer than 4000 people in the United States per year.

The Fenix System was studied in 35 adults who failed conventional medical therapy for treating fecal incontinence. Study evaluations were performed before and after the procedure and at 6 weeks, 3 months, 6 months, and 12 months postimplantation. The 15 participants studied at US sites will be followed annually for 5 years postimplant.

After 12 months, 62.9% of the patients experienced reductions of fecal incontinence episodes by half or more, 54.3% had reductions in fecal incontinence days by half or more, and in 37.1%, urgent episodes dropped by half or more.

Subjects also showed improvements in quality-of-life measures including depression, self-perception, and feelings of embarrassment.

Adverse events in the clinical trial included pain, infection, impaction or defecatory disorder, device erosion, device removal/reoperation, and bleeding.

The Fenix System should not be implanted in patients with suspected or known allergies to titanium, and the sizing tool and introducer tool should not be used in patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.

After implantation, patients should not be exposed to magnetic resonance imaging (MRI), as it could interfere with the magnetic strength and the function of the device. If the patient needs an MRI and no alternative diagnostic procedure can be used, the implant can be safely removed.

Physicians should recommend to patients receiving the Fenix System to register their implant with the MedicAlert Foundation or an equivalent organization, the FDA advises.

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