FDA approves implant as colostomy alternative
Implant controls fecal incontinence
American Medical Systems in Minneapolis recently received approval from the Rockville, MD-based Food and Drug Administration (FDA) to market the Acticon Neosphincter for the treatment of severe fecal incontinence as an alternative to colostomy, sphincteroplasty, or graciloplasty, the three currently available surgical treatments for managing this condition.
The device is an implantable prosthesis designed to simulate the natural function of the anal sphincter muscles, giving the patient control over bowel movements. The FDA approved the Acticon prosthesis for men and women who suffer from severe fecal incontinence, defined as loss of solid or liquid stool at least once weekly. The Acticon device was designated as a Humanitar ian Use Device by the FDA because severe fecal incontinence affects fewer than 4,000 patients a year in the United States.
The device consists of these main components:
• a cuff placed around the anal canal;
• a pressure-regulating balloon implanted in the abdomen;
• a control pump in the scrotum or labia.
The patient controls bowel movements by manipulating the pump to open or close the anal canal. A colorectal surgeon implants the device during an inpatient surgical procedure. The device has been successfully implanted in more than 230 patients worldwide.
[For more information, call toll-free (800) 328-3881 or visit www.visitAMS.com.]
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