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Revised: May 4, 2000
FOR IMMEDIATE RELEASE
HCFA PANEL AFFIRMS EFFECTIVENESS OF SACRAL NERVE STIMULATION FOR TREATMENT OF URINARY CONTROL PROBLEMS
BALTIMORE -- Oct. 19, 2000 -- Medtronic, Inc. (NYSE:MDT), received a resounding vote of confidence here yesterday for its implantable treatment for urinary control problems that will likely result in a national Medicare coverage policy for sacral nerve stimulation.
The Medical and Surgical Procedures Panel of the Health Care Financing Administration's (HCFA) Medicare Coverage Advisory Committee (MCAC) unanimously affirmed the effectiveness of Medtronic's InterStim Therapy for Urinary Control, which uses sacral nerve stimulation, to treat patients with refractory urinary urge incontinence and urgency-frequency. Based on the expert panel's conclusion, which was informed by extensive technology assessment reports prepared by the Blue Cross and Blue Shield Association, HCFA will decide whether to set a national Medicare coverage policy for sacral nerve stimulation within 60 days.
HCFA is the government agency that sets policy for Medicare and Medicaid, two bellwethers in health insurance that combined cover an estimated 75 million Americans. MCAC consists of medical specialty panels and an executive committee that advises HCFA on whether specific medical products and services are scientifically proven to be effective.
Indicated for the treatment of urinary urge incontinence, nonobstructive urinary retention and significant symptoms of urgency-frequency when drugs prove inadequate or cause intolerable side effects, InterStim Therapy uses an implanted medical device called a neurostimulator to deliver mild electrical stimulation to the sacral nerves, which are located in the lower back and influence bladder function.
"The panel's recommendation aligns with clinical data showing that sacral nerve stimulation is a safe and effective therapy for patients who don't respond favorably to front-line treatments," said Martha Goldberg Aronson, General Manager of Medtronic Neurological's Functional Stimulation business, which includes InterStim Therapy. "Medicare coverage of InterStim Therapy would provide a new treatment option for thousands of patients with urinary control problems who do not receive adequate relief from behavioral and pharmacological therapy."
In a clinical study, InterStim Therapy has shown sustained clinical benefit in implanted patients. At the 12-month follow-up exam, the study showed that:
- 73 percent of patients with urinary urge incontinence achieved a reduction in leaking episodes per day of 50 percent or more -- meaning they stayed dry more often than before receiving InterStim Therapy.
- 55 percent of patients with urgency-frequency experienced an increase in volume voided per void of 50 percent or more -- meaning a greater volume of urine was voided during each voiding episode after receiving InterStim Therapy, as compared to baseline.
There were no reports of permanent injury associated with the devices or use of sacral nerve stimulation. 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
Since its initial market clearance by the U.S. Food and Drug Administration in September 1997, InterStim Therapy has continued to gain acceptance among payors, as hundreds of U.S. payors now provide coverage. Most private insurance plans evaluate sacral nerve stimulation therapies on a case-by-case basis.
InterStim Therapy costs approximately $10,000, including the neurostimulator and lead. Physician and hospital fees vary and can range from $15,000 to $20,000. The annual cost to the U.S. healthcare system for treating patients suffering from urinary incontinence 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."
Urge incontinence and urgency-frequency -- two urinary control problems that are often embarrassing and sometimes disabling conditions affecting an estimated 17 million Americans -- rank among the most common voiding dysfunctions. Urge incontinence is characterized by the sudden, strong urge to urinate, followed by the involuntary loss of urine, or leaking. Symptoms of urgency-frequency include the urgent need to urinate -- in severe cases as many as 40 times per day. Current treatments include pelvic floor exercises, drug therapy, biofeedback, neurostimulation, and surgery to augment the bladder.
More information on InterStim Therapy can be found online at www.interstim.com. Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com.