Torax Awarded FDA Approval for Fecal Incontinence System
The FDA has cleared for marketing Torax Medical’s Fenix continence restoration system for the treatment of fecal incontinence.
The implant contains a series of titanium beads with magnetic cores, in which their attractive force augments the anal sphincter to minimize involuntary opening of the anal canal.
It also features an anal sphincter sizing tool to determine an appropriate size for the implant, as well as an introducer tool to guide the sizing tool and the implant into position.
Approval of the system was based on a study of 35 adults who failed conventional medical therapy for treating fecal incontinence. Twelve months after implantation, 62.9 percent of patients experienced a reduction of fecal incontinence episodes by half or more, while 54.3 percent experienced a reduction in fecal incontinence days by half or more. — Michael Cipriano