DBS Therapy from Medtronic offers an adjustable, reversible (by turning off or removing the system) method of treatment for dystonia.
DBS uses a small, pacemaker-like device, placed under the skin of the chest, to send electronic signals to an area in the brain that controls movement.
One neurostimulator is needed for treatment of dystonia. The implanted components are:
The device settings and stimulation levels can be adjusted non-invasively by a clinician using a programming device.
DBS Therapy for dystonia may help control your symptoms, but it is not a cure. When you turn on the brain stimulation system, it will deliver stimulation that may decrease some or all of your symptoms. Your symptoms will return when the system is turned off.
Risks of DBS can include risks of surgery, side effects, or device complications. Please refer to Risks and Probable Benefits for more information.
Neurologists and neurosurgeons have used electrical stimulation since the 1960s as a way to locate and distinguish specific sites in the brain. Medtronic developed brain stimulation technology in the 1980s in conjunction with leading international physician researchers.
Medtronic DBS Therapy is currently approved to treat Parkinson's disease and essential tremor, and as a Humanitarian Device to treat dystonia, epilepsy and obsessive-compulsive disorder. Since 1997, more than 135,000 patients worldwide have received Medtronic DBS Therapy.
The Food and Drug Administration (FDA) approved Medtronic DBS Therapy in 2003 as a Humanitarian Use Device. A Humanitarian Use Device is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 new people in the United States each year.
The FDA reviewed the safety of Medtronic DBS Therapy for dystonia and determined that the probable health benefits outweigh the risks of injury or illness from its use. Efficacy of treatment (effectiveness) has not been established by large clinical trials. Surgery to implant the system can only be performed in a medical center whose institutional review board has approved use of the device.
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