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The Food and Drug Administration (FDA) approved Medtronic DBS Therapy for dystonia in 2003 as a Humanitarian Device. A Humanitarian 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.