FDA approves Fenix Continence Restoration System to treat faecal incontinence- Torax Medical

The FDA has approved the Fenix Continence Restoration System from Torax Medical to treat faecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options.

The Fenix System has three components: an implant, an anal sphincter sizing tool and an introducer tool. The implant is a series of titanium beads with magnetic cores that are connected by titanium wires to form a ring shape. The attractive force of the magnetic beads augments the anal sphincter to minimize involuntary opening of the anal canal, reducing the likelihood of severe faecal incontinence. The implant device is offered in multiple sizes to accommodate variation in sphincter size. The sizing tool is used to associate the anal sphincter size to an appropriate implant. The introducer tool is used to guide the sizing tool and the implant into position.

The Fenix System was studied in 35 adults who failed conventional medical therapy for treating faecal incontinence. After 12 months, 62.9% of participants experienced a reduction of faecal incontinence episodes by half or more; 54.3% experienced a reduction in faecal incontinence days by half or more; and 37.1% experienced a reduction in urgent episodes by half or more. Study participants also showed improvements in quality of life measures including improvements in depression, self-perception, and feelings of embarrassment.

Comment: The Fenix Continence Restoration System received a CE Mark on 14 November 2011.