Medtronic Inc. said Friday that it has received Food and Drug Administration approval for an implantable device to help patients better control their bowel movements.
The product, called InterStim Therapy for Bowel Control, is for patients who have chronic fecal incontinence that have failed or aren't qualified for more conservative treatments, Medtronic said.
Users will be implanted with a neurostimulator and a thin wire to stimulate the sacral nerves, which control the bowel. Patients and clinicians will be able to adjust the stimulation and switch the device on and off.
"Medtronic's InterStim Therapy is an important advance for patients who see their quality of life diminished by bowel control problems," said Tom Tefft, president of Medtronic's neuromodulation business. "This approval reflects our ongoing commitment to extend our expertise to additional serious, chronic diseases where there are few other current treatment options for patients."
The Fridley company said it conducted a study that involved 120 patients to determine the effectiveness of the therapy. After a year, 83 percent of patients said it cut fecal incontinent episodes at least in half, Medtronic said.
More than 40 percent of the patients said they had no more incontinent episodes.
WENDY LEE
