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Medtronic to Pursue Pivotal Trials of Treatments for Overactive Bladder and Enlarged Prostate |
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23 May 2006 |
MINNEAPOLIS, IN, USA | May 22, 2006 | Medtronic, Inc. (NYSE: MDT), today announced its intentions to pursue two separate pivotal trials of the company’s commercially available urological therapies: InterStim Therapy for Urinary Control, a treatment for overactive bladder and urinary retention; and PROSTIVA™ RF Therapy, a treatment for symptomatic benign prostatic hyperplasia (BPH).
Announced during the American Urological Association meeting in Atlanta, these post-market studies will be designed to establish higher levels of clinical evidence for practical use of InterStim and PROSTIVA RF Therapies – and drive them toward standard of care.
“Clinical trials that establish Class I evidence pave the way for most treatments that are recognized as standards of care,” said Dr. Richard E. Kuntz, M.D., president of the Medtronic division that includes the company’s urological therapies. “With that notion in mind, we intend to initiate two separate clinical trials – one for InterStim Therapy; the other for PROSTIVA RF Therapy – within the next year in order to drive each therapy in that direction. Once we arrive at the desired destination – and increasingly along the way there – we are confident that more patients who can benefit from our urological therapies will actually get them routinely as part of standard medical practice.”
Class I evidence is defined as clinical data that demonstrates substantial benefit versus risk of a therapy for specific patient populations.
These trials are expected to further demonstrate these urological therapies’ positive impacts on outcomes in broad patient populations. Furthermore, the results are expected to aid physicians in determining at what point each therapy should be considered during the progression of the relevant condition.
InterStim Therapy for Urinary Control uses sacral nerve stimulation to improve bladder function. Originally approved by the FDA in 1997, it is indicated for the treatment of non-obstructive urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients for whom more conservative treatments have failed or caused intolerable side-effects. Overactive bladder affects 33 million people in the United States alone. Worldwide, more than 25,000 people have been treated with InterStim Therapy.
PROSTIVA RF Therapy delivers low-level radio frequency energy through the urethra to destroy a well-defined region of the enlarged prostate and improve urine flow that has been restricted because of benign prostatic hyperplasia (BPH), a common urological condition affecting half of men over age 50 and 80 percent of men over age 80. Originally cleared by the FDA in 1996, RF therapy is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to BPH in men over the age of 50 with prostate sizes between 20 cm3 and 50 cm3. Approximately 8.4 million American men over age 50 are candidates for treatment of BPH. More than 80,000 men worldwide have been treated for symptomatic BPH with RF therapy.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
SOURCE: Medtronic, Inc |
