Torax Medical (Shoreview, MN) won FDA approval to introduce its FENIX continence restoration system for patients for whom other existing treatment options are not appropriate or have not worked. The FENIX is essentially similar to the company’s LINX gastroesophageal reflux management product. (LINX is a bracelet made of magnetic beads that sits around the esophagus). While the LINX stops acid from rising up from the stomach by contracting the lower esophageal sphincter, the FENIX prevents involuntary discharge toward the other end of the GI tract.
The FENIX helps to contract the anal sphincter, keeping it closed unless sufficient force is voluntarily applied during trips to the bathroom. As soon as the pressure lets off, and bracelet contracts back to its original position.
The device is implanted using a single incision and the size of the bracelet is determined using a provided tool. X-rays are used to confirm the appropriate size of the implant and following the procedure to make sure the FENIX fits well.
From the FDA statement regarding the study that led to the approval:
The Fenix System was studied in 35 adults who failed conventional medical therapy for treating fecal incontinence. Study evaluations were performed before and after the procedure and at six weeks, three months, six months and 12 months post-implant. The 15 participants studied at U.S. sites will have annual evaluations until five years after the device was implanted.
Probable benefits were evaluated using a bowel diary to track fecal incontinence events and by a validated, disease-specific questionnaire called the Fecal Incontinence Quality of Life Scales to quantify changes in quality of life before and after implantation of the Fenix System. After 12 months, 62.9 percent of participants experienced a reduction of fecal incontinence episodes by half or more; 54.3 percent experienced a reduction in fecal incontinence days by half or more; and 37.1 percent 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. These results suggest that patients with fecal incontinence could benefit from the device when they have failed other fecal incontinence therapies.
Flashbacks: FDA Approves LINX Gastroesophageal Reflux Management System…; LINX Anti-Reflux Treatment to Provide Relief for Europeans With Acid Reflux…
Product page: FENIX Continence Restoration System…
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