Medtronic files premarket approval application for InterStim therapy

InterStim therapy is a reversible treatment for patients with fecal incontinence after conservative treatments have failed. Once approved by the FDA, InterStim therapy for fecal incontinence will be the only therapy that allows patients and physicians to trial the therapy with a minimally invasive test stimulation to confirm its effect prior to the device implant, the company said.

InterStim therapy for fecal incontinence delivers the neurostimulation to the sacral nerve to stimulate the nerves and muscles that control bowel movements. Based on average regulatory review timelines, Medtronic is preparing to commercialize InterStim therapy for fecal incontinence in the US in 2009.

Richard Kuntz, president of neuromodulation business at Medtronic, said: “This premarket approval application is a demonstration of our commitment to InterStim therapy and represents significant clinical research in the treatment of another debilitating pelvic health disorder where there is unmet medical need.”