Medtronic Initiates Long-Term, Post-Market Study with InterStim(R) Therapy for Overactive Bladder.Study Designed to Strengthen Evidence for InterStim Therapy as Standard of Care MINNEAPOLIS -- Medtronic, Inc. (NYSE NYSE See: New York Stock Exchange :MDT MDT abbr. Mountain Daylight Time MDT (in the US and Canada) Mountain Daylight Time MDT n abbr (US) (= mountain daylight time) → ) announced today the initiation of the InSite(TM) Trial, a post-market study of its commercially available InterStim([R]) Therapy for Urinary Control, a treatment for overactive bladder Overactive Bladder Definition Overactive bladder is the leakage of large amounts of urine at unexpected times, including during sleep. Description and urinary retention Urinary retention The result of progressive obstruction of the urethra by an enlarging prostate, causing urine to remain in the bladder even after urination. . The U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has approved this study, which will aim to enroll more than 450 patients; those who qualify will be randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. to receive either InterStim Therapy or standard medical treatment, including oral medications as determined by their physician. Patients implanted with InterStim Therapy will be followed out to five years. The results of this trial are expected to provide further clinical evidence of InterStim Therapy's efficacy in treating patients suffering from overactive bladder versus standard medical therapy. "For many patients, a diagnosis of overactive bladder or urinary retention often represents a significant impairment in their quality of life," said Michael E. Carley, M.D., M.S., director of Urogynecology at Baylor University Medical Center Baylor University Medical Center (BUMC) is located at 3500 Gaston Avenue in east Dallas, Texas (USA). Its medical services are often listed in the annual U.S. News & World Report compilation of Best Hospitals. , Dallas and an InSite Trial investigator. "InterStim Therapy has allowed us to provide hope for those patients who were previously told their incontinence was not treatable and had failed all other interventions. The results of this long-term study will equip us with further clinical evidence of the potential benefits of InterStim Therapy for a large patient population and to consider its role in a standard algorithm for the treatment of patients with overactive bladder or urinary retention." The study is designed as a prospective, multicenter, randomized trial comparing InterStim Therapy to standard medical management for patients with symptoms of overactive bladder, including urinary urge incontinence urge incontinence n. Leakage of urine when the desire to void is strong. Also called urgency incontinence. urge incontinence and urgency-frequency. The primary endpoint of the study will be assessed after six months to demonstrate the success rate of InterStim Therapy versus standard medical therapy. The study will provide significant long term safety evidence by following patients receiving InterStim Therapy out to five years. "This clinical trial is one important example of our commitment to ensuring that we have the highest level of clinical evidence to support InterStim Therapy and its role in helping patients who are suffering from the troubling symptoms of overactive bladder," said Richard E. Kuntz, M.D., president of the Neuromodulation business at Medtronic. "We recognize that by further validating the clinical evidence with InterStim Therapy, we also improve the chances that more patients who will truly benefit from this therapy will have access to it." InterStim Therapy for Urinary Control uses sacral nerve sacral nerve n. Any of five nerves emerging from the sacral foramina: the first three enter into the formation of the sacral plexus, and the second two into the coccygeal plexus. stimulation to improve bladder function. Originally approved by the FDA in 1997, it is indicated for the treatment of non-obstructive urinary retention and 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 40,000 people have been treated with InterStim Therapy. About the Neuromodulation Business at Medtronic Medtronic developed and leads the field of neuromodulation, the targeted and regulated delivery of electrical pulses and pharmaceuticals to specific sites in the nervous system. The company's Neuromodulation business offers innovative therapies for chronic pain, movement disorders, spasticity spasticity /spas·tic·i·ty/ (spas-tis´i-te) the state of being spastic; see spastic (2). spas·tic·i·ty n. 1. A spastic state or condition. 2. Spastic paralysis. , overactive bladder, benign prostatic hyperplasia benign prostatic hyperplasia n. Abbr. BPH A nonmalignant enlargement of the prostate gland commonly occurring in men after the age of 50, and sometimes leading to compression of the urethra and obstruction of the flow of urine. and gastroparesis. 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. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results. |
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