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Medicare Sets National Policy for Sacral Nerve Stimulation as Treatment for Urinary Control Problems

Decision will expand patient access to InterStim Therapy from Medtronic

MINNEAPOLIS –– Jan. 3, 2002 –– Beginning Jan. 1, thousands of patients with urinary control problems gained expanded access through Medicare to an effective and long-term treatment for their debilitating, often embarrassing, condition.

Following last year’s recommendation from the Medicare Coverage Advisory Committee (MCAC), the Centers for Medicare and Medicaid Services (formerly the Health Care Finance Administration) has adopted a new national coverage standard for the treatment, giving patients uniform access to InterStim Therapy starting in 2002.

“This coverage decision emphasizes our commitment to making the best in proven new technologies available to Medicare beneficiaries,” said Tommy Thompson, Health and Human Services Secretary, in a statement issued in June regarding the MCAC recommendation. “This is especially important because incontinence affects so many Medicare beneficiaries, and this procedure can significantly improve many people’s quality of life.”

Indicated for the treatment of urinary urge incontinence, non-obstructive urinary retention and significant symptoms of urgency-frequency for patients who have failed or could not tolerate more conservative therapies, InterStim Therapy uses an implanted medical device akin to a cardiac pacemaker to deliver mild electrical stimulation to the sacral nerves, which are located in the lower back and influence bladder function.

Urge incontinence is characterized by the sudden, strong urge to urinate, followed by the involuntary loss of urine, or leaking. Urgency-frequency includes the urgent need to urinate –– in severe cases as many as 40 times per day. And non-obstructive urinary retention is marked by the inability to completely empty the bladder. Combined, these three conditions afflict more than 17 million Americans.

“This new policy will allow many more patients suffering from incontinence and other urinary control problems to take advantage of sacral nerve stimulation,” said Nancy Muller, executive director of the National Association for Continence. “With so few effective treatment options available to patients with urinary control problems, broader insurance coverage for proven treatments such as InterStim Therapy is both welcome and needed.”

The annual cost to the U.S. healthcare system for treating patients suffering from urinary incontinence alone exceeds $15 billion, according to a 1996 report published by the Department of Health and Human Services called “Urinary Incontinence in Adults: Acute and Chronic Management.” The new standards ensure universal Medicare coverage of InterStim Therapy, including the associated physician and hospital fees.

“We’re pleased by the good news this national coverage policy brings to long-suffering patients who do not receive adequate relief from behavioral and medical therapy,” said Martha Goldberg Aronson, vice president and general manager of Medtronic’s Gastroenterology/Urology business, which includes InterStim Therapy.

InterStim Therapy has shown sustained clinical benefit in many implanted patients. One study showed that 75 percent of patients with urinary urge incontinence achieved a reduction in leaking episodes per day of 50 percent or more at six months. Approximately 54 percent of patients with urgency-frequency experienced an increase in volume voided per void of 50 percent or more six months after receiving InterStim Therapy, as compared to baseline.

The same study showed no reports of permanent nerve injury associated with the devices or use of sacral nerve stimulation (nine percent of adverse events were not resolved at the time of the database closure). About one-third of the patients who received the InterStim device underwent subsequent surgery to reposition or replace elements of their systems. The adjustments were intended to resolve device- or therapy-related side effects. The surgical revisions did not preclude a favorable clinical outcome for patients.

Prior to the availability of InterStim, current treatments for urinary control problems were limited to pelvic floor exercises, drug therapy, biofeedback and surgery to augment the bladder.

For more information about the National Association for Continence, please call 1-800-BLADDER or visit www.nafc.org.

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 can be found online at www.interstim.com or by calling 1-800-664-5111, 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 the company’s Annual Report on Form 10-K for the year ended April 27, 2001. Actual results may differ materially from anticipated results.