- U.S. FDA approves Torax Medical’s FENIX Continence Restoration system
- The FENIX is recommended for people with fecal incontinence for whom other treatment options are inappropriate
- The system consists of three components: an implant, an anal sphincter sizing tool, and an introducer tool
- Fecal incontinence is a lack of control over defecation, leading to involuntary loss of bowel contents
- Fecal incontinence is a common condition and affects people of all ages
Torax Medical, a medical technology company, based in St. Paul, Minnesota, has received U.S. Food and Drug Administration (FDA) approval for its FENIX Continence Restoration system. The FENIX is recommended for people with fecal incontinence for whom other treatment options are improper or have not worked.
Fecal incontinence is known by many names including faecal incontinence, bowel incontinence, anal incontinence, accidental bowel leakage, and encopresis. The condition is a lack of control over defecation, leading to involuntary loss of bowel contents – including solid feces, liquid stool elements and mucus, or flatus (gas). Fecal incontinence is a symptom or sign, not a diagnosis.
Fecal incontinence is a common condition and affects people of all ages. However, the condition is common in older adults. One analysis stated a prevalence of 2.2% in the general population. Females are more likely to develop it than males.
The FENIX is similar to the company’s LINX gastroesophageal reflux management product. LINX received FDA approval in 2012. LINX system is a bracelet made of magnetic beads that sits around the esophagus.
FENIX system consists of three components:
- an implant,
- an anal sphincter sizing tool,
- an introducer tool.
From FDA Press Announcement:
The implant is a line of titanium beads with magnetic cores connected by titanium wires to form a ring shape. The attractive force of the magnetic beads augments the anal sphincter to minimize the involuntary opening of the anal canal. This reduces the likelihood of severe fecal incontinence. The implant device is provided in various sizes to accommodate variation in sphincter size. The sizing tool is used to associate the anal sphincter size to a right implant. The introducer tool is utilized to guide the sizing tool and the implant into position.
The system should not be implanted in patients with allergies to titanium. The sizing tool and introducer tool should not be used in patients with allergies to titanium, ferrous materials, stainless steel, or nickel.
According to the FDA, the implant is magnetic resonance unsafe. After implantation, patients should not be allowed in a magnetic resonance imaging (MRI) environment as it could interfere with the magnetic strength of the device.
A recommendation should be made to individuals receiving the FENIX System to register their implant with the MedicAlert Foundation, Turlock, California or a similar organization. In the event alternative diagnostic methods cannot be used, and MRI is needed, the implant can be removed harmlessly.
Unfavorable events recognized in the clinical trial for the FENIX System include pain, infection, impaction or defecatory disorder, device erosion, device removal/re-operation, and bleeding.
Product page: THE FENIX CONTINENCE RESTORATION SYSTEM