Healthcare Industry News: Activa
News Release - April 3, 2006
Neurology Academy Upgrades Deep Brain Stimulation in Latest Parkinson's Treatment GuidelinesMINNEAPOLIS--(HSMN NewsFeed)--April 3, 2006--The latest American Academy of Neurology (AAN) treatment guidelines for Parkinson's disease (PD) released today include an upgrade for deep brain stimulation (DBS). The upgrade raises DBS of the subthalamic nucleus (STN) to the status of a treatment option for patients with motor complications.
The guidelines were released at the AAN 58th Annual Meeting in San Diego, and state: "DBS of the STN may be considered as a treatment option in PD patients to improve motor function and to reduce motor fluctuations, dyskinesia and medication usage. Patients need to be counseled regarding the risks and benefits of this procedure."
The recommendations position DBS of the STN - one of the approved target sites for ActivaŽ Therapy from Medtronic (NYSE:MDT ) - as a treatment option for Parkinson's disease, according to Dr. C. Warren Olanow, M.D., Professor and Chair of the Department of Neurology at the Mount Sinai School of Medicine in New York.
"DBS of the STN can reliably achieve dramatic and long-lasting results, especially in younger patients with motor complications that are not adequately controlled with medication," said Dr. Olanow, who served as one of the original investigators for the global clinical trial of DBS in the treatment of Parkinson's disease. This study reported that DBS of the STN increased "ON" time without dyskinesia - that is, the time when the patient experiences good motor control without complicating involuntary movements - from 27 percent of a patient's waking day to 74 percent of a patient's waking day.
"The published results of the study demonstrated the remarkable power of DBS to improve patients whose motor symptoms could not otherwise be controlled with medication," said Dr. Olanow, who is also Professor of Neuroscience at Mount Sinai and former President of the Movement Disorder Society. "More importantly, I have seen the impact DBS has made on patients in my own practice. The AAN guidelines should cause more neurologists to consider DBS of the STN in the management of Parkinson's patients."
Target site selection for DBS in the treatment of Parkinson's disease continues to be studied. Two sites for this indication have been approved by the U.S. Food and Drug Administration (FDA): the STN and the internal globus pallidus (GPi). According to the treatment's labeling: "Bilateral stimulation of the STN or GPi using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication."
More than 30,000 people worldwide have received Activa Therapy. According to a survey conducted by Medtronic in January 2006, two out of three implanted patients said they wished that they had opted for Activa Therapy sooner.
"As the pioneer of deep brain stimulation technology and the driver to establish it as a standard of care through past and ongoing studies, we're pleased with the AAN's latest practice guidelines for Parkinson's disease and their recommendations for DBS," said Todd Langevin, Vice President of Medtronic Neurological's Global Movement Disorders business. "We remain committed to achieving further Class I evidence for Activa Therapy so that more neurologists begin to consider it sooner for their Parkinson's patients."
Activa Parkinson's Control Therapy received European regulatory approval in 1998 and FDA approval in 2002. The U.S. Centers for Medicare and Medicaid Services approved it for national Medicare coverage in April 2003. Activa Therapy has evolved as a method of care for Parkinson's patients when medication alone fails to provide adequate benefit or causes intolerable side effects.
Activa Therapy stimulates structures deep within the brain that influence motor control. The stimulation is adjustable to meet the needs of individual patients and can be turned off if necessary. It appears to modify brain signals that cause the stiffness, slowness of movement, and/or shaking that characterize the disease.
Information for patients about Activa Therapy can be obtained online at www.newhopeforparkinsons.com or by calling 1-800-675-5752.
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 Quarterly Report on Form 10-Q for the quarter ended January 27, 2006. Actual results may differ materially from anticipated results.
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