Torax Medical announced today that the FENIX Continence Restoration System, an innovative approach to the treatment of fecal incontinence (FI), has received FDA approval under a humanitarian device exemption (HDE).

FI is the inability to control bowel movements due to a damaged or weak anal sphincter muscle. The problem affects predominately women and is often an injury associated with childbirth. It is a condition that can occur at any age and is often devastating to a person’s quality of life. For older people, fecal incontinence often results in early institutionalization because family members have difficulty coping with the problem at home.

Torax Medical President and CEO Todd Berg said, “The FENIX Continence Restoration System represents a vital treatment option for patients suffering from this debilitating problem. The FENIX device builds on our Magnetic Sphincter Augmentation (MSA) technology that has been proven to be effective in treating gastro-esophageal reflux disease (GERD) with our LINX Reflux Management System. The FENIX device has been successively marketed in Europe since 2011; we are excited to now have this procedure available for patients in the U.S.”

“The FENIX device is a welcome addition to the limited number of treatment options currently available for patients suffering from fecal incontinence,” said Anders Mellgren, M.D., Ph.D., FACS, FASCRS, professor of the chief division of colon and rectal surgery in the Department of Surgery at the University of Illinois at Chicago. “This treatment option preserves the native anatomy and can offer the patient more control and improved quality of life. The FENIX device begins working immediately and importantly does not require any patient interaction or adjustments by a physician.”

Torax is a privately held medical device company based in St. Paul, Minn. It develops and markets products that are designed to treat sphincter disorders by utilizing its MSA technology platform.