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Medtronic Marks 10,000th Implant of its InterStim® Therapy
Medtronic Marks 10,000th Implant of its InterStim® Therapy
Pacemaker-like Device Stimulates Nerves That Influence Pelvic Floor to Control Urinary Dysfunctions
MINNEAPOLIS — September 18, 2003 — Medtronic, Inc., (NYSE: MDT), announced this week that a 25-year-old Illinois woman is the 10,000th patient to receive its InterStim® Therapy for Urinary Control.
Serge Marinkovic, M.D., Decatur, Ill., performed the implant for Tiffany Gould of Decatur who had suffered awkward, embarrassing lifestyle limitations because of pelvic floor dysfunction and urinary incontinence manifested as urgency, frequency and retention.
“My experience told me that sacral nerve stimulation would do the job,” Dr. Marinkovic said. “Here we had a person up six or seven times a night and voiding 17 times a day or more. So it wasn’t difficult to get Mrs. Gould to agree to InterStim Therapy. When other methods don’t work, and when there’s no tract obstruction, sacral nerve stimulation is rapidly becoming the standard of care.” Dr. Marinkovic has provided it for about 50 patients in less than two years.
Before InterStim Therapy, Gould tried biofeedback, various forms of bladder training and diet modification. Then came pelvic floor exercises and prescription drugs pyridium, Ditropan™ and others.
Now, with InterStim® Therapy since Aug. 15, Gould feels she’s found success. “My life has changed completely. The incontinence used to control my lifestyle. Now I control my incontinence.
“There’s no more embarrassment. There’s no outward sign. Unless I tell them, nobody knows. But I’m so happy with the results, I tell everybody. I’m in control now.”
Introduced in the United States for the treatment of urinary urge incontinence by Medtronic in 1997, the indications for InterStim Therapy now include nonobstructive urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination.
“Medtronic Urology is gratified by the growing acceptance of InterStim Therapy,” said Tommy Johns, vice president and general manager, Medtronic Urology. “Mrs. Gould’s experience is not an uncommon outcome of InterStim Therapy and illustrates how this technology can impact a person’s quality of life. This is why we are strongly committed to do all we can to increase physician and patient awareness that another proven treatment option exists for voiding dysfunction.”
An international panel of urologists, reporting in the British Journal of Urology International (Vol. 91, Issue 4) concluded that sacral nerve stimulation is becoming the standard of care for intractable cases of overactive bladder and nonobstructive urinary retention. In evaluating the accumulation of data, the panelists noted that 76 percent of people who received the stimulation therapy achieved a clinical benefit, defined as either complete relief from incontinence or at least a 50 percent reduction in leakage episodes. Evidence based on a quality-of-life questionnaire also suggests that patients studied perceived their changed conditions as having a positive effect on their quality of life.
Urinary incontinence affects about 25 million Americans , with an annual cost to the U.S. health care system exceeding $15 billion . The problem is twice as common in women as in men. The National Association for Continence estimates that one in four women between the ages of 30 and 59 has experienced an incontinence episode and that incontinence afflicts about half of all nursing home residents .
InterStim Therapy uses an implanted medical device similar to a pacemaker to deliver mild electrical stimulation via implanted electrodes to the sacral nerves, which are located near the tailbone and influence bladder function. Before receiving the implanted device, candidates undergo a minor surgical procedure and home test period to assess effectiveness. The stimulation can be discontinued or the device removed at any time.
While Gould has not experienced side effects, no therapy is without risks. In addition to the risk related to a surgical procedure, complications from sacral nerve stimulation can include pain, infection, transient electrical shock, lead migration and adverse change in bowel function. These complications generally were resolvable in clinical studies of the therapy.
The U.S. Centers for Medicare and Medicaid Services (CMS) adopted a national coverage standard for the treatment in January of 2002, making it available for all appropriate Medicare recipients. Many private insurance carriers also cover the therapy.
InterStim Therapy is a leading product in the Medtronic suite of medical technologies for the diagnosis and treatment of urological conditions. Medtronic Urology (www.medtronic-urology.com) also offers TUNA® Therapy, a minimally-invasive treatment for benign prostatic hyperplasia (BPH), which uses radiofrequency energy to destroy prostate tissue. Medtronic Urology also is a leader in functional urodiagnostic 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 online at www.interstim.com or can be obtained by calling 1-800-664-5111, extension 3000.
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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 25, 2003. Actual results may differ materially from anticipated results.
Contact:
Chris King, Investor Relations, 763-505-2695, [email protected]
Bob Hanvik, Public Relations, 763-505-2635, [email protected]
Pacemaker-like Device Stimulates Nerves That Influence Pelvic Floor to Control Urinary Dysfunctions
MINNEAPOLIS — September 18, 2003 — Medtronic, Inc., (NYSE: MDT), announced this week that a 25-year-old Illinois woman is the 10,000th patient to receive its InterStim® Therapy for Urinary Control.
Serge Marinkovic, M.D., Decatur, Ill., performed the implant for Tiffany Gould of Decatur who had suffered awkward, embarrassing lifestyle limitations because of pelvic floor dysfunction and urinary incontinence manifested as urgency, frequency and retention.
“My experience told me that sacral nerve stimulation would do the job,” Dr. Marinkovic said. “Here we had a person up six or seven times a night and voiding 17 times a day or more. So it wasn’t difficult to get Mrs. Gould to agree to InterStim Therapy. When other methods don’t work, and when there’s no tract obstruction, sacral nerve stimulation is rapidly becoming the standard of care.” Dr. Marinkovic has provided it for about 50 patients in less than two years.
Before InterStim Therapy, Gould tried biofeedback, various forms of bladder training and diet modification. Then came pelvic floor exercises and prescription drugs pyridium, Ditropan™ and others.
Now, with InterStim® Therapy since Aug. 15, Gould feels she’s found success. “My life has changed completely. The incontinence used to control my lifestyle. Now I control my incontinence.
“There’s no more embarrassment. There’s no outward sign. Unless I tell them, nobody knows. But I’m so happy with the results, I tell everybody. I’m in control now.”
Introduced in the United States for the treatment of urinary urge incontinence by Medtronic in 1997, the indications for InterStim Therapy now include nonobstructive urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination.
“Medtronic Urology is gratified by the growing acceptance of InterStim Therapy,” said Tommy Johns, vice president and general manager, Medtronic Urology. “Mrs. Gould’s experience is not an uncommon outcome of InterStim Therapy and illustrates how this technology can impact a person’s quality of life. This is why we are strongly committed to do all we can to increase physician and patient awareness that another proven treatment option exists for voiding dysfunction.”
An international panel of urologists, reporting in the British Journal of Urology International (Vol. 91, Issue 4) concluded that sacral nerve stimulation is becoming the standard of care for intractable cases of overactive bladder and nonobstructive urinary retention. In evaluating the accumulation of data, the panelists noted that 76 percent of people who received the stimulation therapy achieved a clinical benefit, defined as either complete relief from incontinence or at least a 50 percent reduction in leakage episodes. Evidence based on a quality-of-life questionnaire also suggests that patients studied perceived their changed conditions as having a positive effect on their quality of life.
Urinary incontinence affects about 25 million Americans , with an annual cost to the U.S. health care system exceeding $15 billion . The problem is twice as common in women as in men. The National Association for Continence estimates that one in four women between the ages of 30 and 59 has experienced an incontinence episode and that incontinence afflicts about half of all nursing home residents .
InterStim Therapy uses an implanted medical device similar to a pacemaker to deliver mild electrical stimulation via implanted electrodes to the sacral nerves, which are located near the tailbone and influence bladder function. Before receiving the implanted device, candidates undergo a minor surgical procedure and home test period to assess effectiveness. The stimulation can be discontinued or the device removed at any time.
While Gould has not experienced side effects, no therapy is without risks. In addition to the risk related to a surgical procedure, complications from sacral nerve stimulation can include pain, infection, transient electrical shock, lead migration and adverse change in bowel function. These complications generally were resolvable in clinical studies of the therapy.
The U.S. Centers for Medicare and Medicaid Services (CMS) adopted a national coverage standard for the treatment in January of 2002, making it available for all appropriate Medicare recipients. Many private insurance carriers also cover the therapy.
InterStim Therapy is a leading product in the Medtronic suite of medical technologies for the diagnosis and treatment of urological conditions. Medtronic Urology (www.medtronic-urology.com) also offers TUNA® Therapy, a minimally-invasive treatment for benign prostatic hyperplasia (BPH), which uses radiofrequency energy to destroy prostate tissue. Medtronic Urology also is a leader in functional urodiagnostic 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 online at www.interstim.com or can be obtained by calling 1-800-664-5111, extension 3000.
- 0 -
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 25, 2003. Actual results may differ materially from anticipated results.
Contact:
Chris King, Investor Relations, 763-505-2695, [email protected]
Bob Hanvik, Public Relations, 763-505-2635, [email protected]
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