Torax Medical said today its Fenix continence restoration system won FDA Humanitarian Device Exemption approval for treating fecal incontinence.
The Fenix system is made up of a series of magnetic titanium beads that are implanted in the anal sphincter to minimize the involuntary opening of the anal canal. The system comes with a tool to size the implant and a tool to guide the implant and sizing tool into position.
“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 technology that has been proven to be effective in treating gastro-esophageal reflux disease 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.,” CEO Todd Berg said in a press release.
“The Fenix device is a welcome addition to the limited number of treatment options currently available for patients suffering from fecal incontinence. 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,” Dr. Anders Mellgren of Chicago’s University of Illinois said in prepared remarks.
The FDA announced the device had been cleared for marketing in mid-December, with indications for treating fecal incontinence in patients who are not candidates for, or have failed with other options to treat the issue.