Medtronic has released the study data of its InterStim therapy to improve bowel control and related quality of life issues.
The US Food and Drug Administration (FDA) approved prospective, multicenter trial is designed to treat chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments.
The study was conducted in 16 centers, including 14 in the US, one in Canada and one in Australia from 2002 to 2010.
InterStim therapy uses an implantable system, consisting of a thin wire lead and a neurostimulator, or pacemaker-like device, as well as external clinician and patient programmers.
The trial demonstrated three-year safety and effectiveness data from 120 patients who had sacral nerve stimulation with implantable InterStim Therapy to treat more than twice-weekly episodes of fecal incontinence.
Medtronic Neuromodulation division Gastro/Urology Therapies vice president and general manager Cindy Kent said its neurostimulation technologies have been shown to have a impact on a chronic, medically refractory conditions.
"This research provides an evidence to support increased physician consideration of InterStim therapy for patients struggling with bowel control problems," Kent said.