Urology Experts: For Some Bladder Control Problems, Sacral Nerve Stimulation Should Be Considered Sooner.

Business Editors/Health/Medical Writers

MINNEAPOLIS--(BUSINESS WIRE)--April 14, 2003

Unique treatment called InterStim(R) Therapy for Urinary Control

is becoming the standard of care for intractable cases of overactive 

bladder and retention, panel concludes

For people with bladder control problems that have proven difficult to treat with medication and other standard measures, a unique therapy that uses an implantable medical device should be considered as a treatment option sooner, an international panel of urologists recommends in the British Journal of Urology International (Vol. 91, Issue 4).

After meeting in August 2002 to review the current treatment continuum for voiding dysfunction, a group of seven interdisciplinary urology experts from the United States, the United Kingdom and Europe concluded that sacral nerve stimulation, or InterStim(R) Therapy for Urinary Control from Medtronic, Inc. (NYSE:MDT), is appropriately becoming the standard of care for the management of intractable cases of overactive bladder and nonobstructive urinary retention. Located in the lower back, the sacral nerves influence bladder function.

In evaluating the data, the experts noted that the majority of the people who received sacral nerve stimulation achieved a clinical benefit, defined as either no incontinence or at least a 50 percent reduction in leakage episodes. Evidence based on a quality-of-life questionnaire also suggests that patients receiving sacral nerve stimulation perceived these changes as having a positive and significant effect on their overall quality of life. Assembled with an educational grant from Medtronic, the independent panel based its recommendations on pivotal data from a large randomized trial.

"With the support of an increasing amount of published data over the past decade, sacral nerve stimulation is now becoming the standard of care for refractory overactive bladder or retention in medical centers around the world," said panelist Steven Siegel, M.D., head of the Center for Continence Care at Metropolitan Urologic Specialists in St. Paul, Minn. "If initial management of overactive bladder or retention with conservative measures, including drugs, behavioral modification and exercise, don't provide sufficient improvement, sacral nerve stimulation is the most appropriate treatment option."

In addition, the panel recommended that given the potential benefits, sacral nerve stimulation should be included in all female urology and incontinence training programs. It also noted that, since the completion of earlier studies on sacral nerve stimulation, procedural advances including new, less invasive technology and surgical techniques have led to greater acceptance among the patient and physician community.

According to the American Foundation for Urologic Disease (AFUD), at least 17 million people in the United States alone suffer from symptoms of overactive bladder. Furthermore, the National Bladder Foundation (NBF) points out that aside from physical health implications, people with bladder control problems often suffer from loss of self-esteem, sleep deprivation, symptoms of depression or anxiety, embarrassment, financial distress and restriction of activities.

InterStim Therapy for Urinary Control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urge incontinence and significant symptoms of urgency-frequency, alone or in combination, in patients who have failed or could not tolerate more conservative treatments. The therapy, which uses what is sometimes called a "bladder pacemaker," is not intended for patients with mechanical obstruction such as benign prostatic hyperplasia (BPH, or enlarged prostate), cancer or urethral stricture.

As with any treatment, InterStim Therapy is not without risks. In addition to the risk related to a medical procedure, complications from this therapy can include pain, infection, transient electrical shock, lead migration and adverse change in bowel function, among others. These complications were generally resolvable in a pivotal FDA clinical trial. InterStim Therapy is completely reversible and may be discontinued at any time.

InterStim Therapy is just one component of Medtronic's suite of technologies for the diagnosis and treatment of urological conditions. Medtronic Urology (www.medtronic-urology.com) also offers TUNA(R) Therapy, a minimally-invasive treatment for benign prostatic hyperplasia (BPH), or enlarged prostate, that utilizes radio frequency (RF) energy to shrink obstructive tissue. It is also the world leader in functional diagnostic equipment.

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. More information on InterStim Therapy is available by visiting www.interstim.com or calling [phone] / ext. 3000.

Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 26, 2002. Actual results may differ materially from anticipated results.

EDITOR'S NOTE: Additional information about bladder control problems and InterStim Therapy can be found at www.medtronic.com/newsroom/media_kits_UrologicalConditions.html.