Medtronic Submitted Pre-Market Approval Application For FDA Approval Of Interstim(R) Therapy For Fecal Incontinence

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 Oct 2008 - 8:00 PDT

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Medtronic, Inc. (NYSE: MDT), today announced that it has submitted its Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for InterStim® Therapy for the treatment of fecal incontinence. 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.

"Many patients with fecal incontinence try to cope with often debilitating symptoms that greatly and adversely affect their quality of life," said Steven D. Wexner, M.D., chief academic officer and chairman, Department of Colorectal Surgery at Cleveland Clinic Hospital in Weston, Florida, and primary investigator in the InterStim Therapy for fecal incontinence clinical trial. "InterStim Therapy for fecal incontinence can provide a significant advance as a new therapeutic option for patients in whom lifestyle and socialization have often been severely restricted due to their incontinence.

InterStim Therapy for fecal incontinence delivers the neurostimulation to the sacral nerve to stimulate the nerves and muscles that control bowel movements. This therapy has been available in markets outside of the United States since 2000 where it has been used by more than 6,000 patients.

"This PMA 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," said Richard E. Kuntz, M.D., corporate senior vice president and president of Medtronic's Neuromodulation business.

Based on average regulatory review timelines, Medtronic is preparing to commercialize InterStim Therapy for fecal incontinence in the United States in 2009.

About Fecal Incontinence

Fecal incontinence is the inability to control your bowels and is a debilitating condition that is often underreported and stigmatized. According to the National Institutes of Health (NIH), more than 5.5 million Americans have fecal incontinence. It is more common in women and adults, but it is not a normal part of aging. Fecal incontinence can be caused by a variety of factors, including constipation, damage to the nerves or muscles in the rectum (from trauma such as childbirth) or other pelvic health disorders. Greater than 50 percent of patients with severe fecal incontinence report a significant impact on quality of life, including impact on their ability to work or engage in social activities.

About Medtronic

Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward‐looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10‐K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.

Medtronic