Torax Medical said the FDA granted premarket approval for its Fenix continence restoration system designed to treat fecal incontinence in patients who are not candidates for, or have failed with other options to treat the issue.
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.
“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. 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,” FDA CDRH Office of Device Evaluation acting director Dr. William Maisel said in an FDA press release.
The device was cleared through a humanitarian use device channel, the company said.
Approval came based on a study of 35 adults who failed conventional medical therapy for the issue. Evaluations were performed pre and post procedure and at 6 weeks, 3 months, 6 months and 12 months post implant, and 15 patients agreed to annual evaluations up to 5 years.
Benefits were analyzed using a bowel diary, and at 12 months, 62.9% of subjects experienced a 50% reduction of fecal incontinence episodes, 54.3% reported a 50% decrease in fecal incontinence days and 37.1% reported reduced urgent episodes by half or more.
Study participants also reported improved quality of life, depression, self-perception and feelings of embarrassment.