FDA approves fecal incontinence system via Humanitarian Exemption

The FDA approved Torax Medical's Fenix Continence Restoration System to treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options. The device is similar to Torax Medical's commercialized Linx Reflux Management System. "Noninvasive treatment options for fecal incontinence, such as drugs, dietary changes and other medical measures, sometimes don't adequately address a patient's symptoms," said Dr. William Maisel, acting director of the Office of Device Evaluation at the FDA's device arm (CDRH). "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 using the humanitarian device exemption pathway for devices that treat rare diseases or conditions. More