Activa® DBS received a Humanitarian Device Exemption from the U.S. Food and Drug Administration (FDA) in April 2003 for primary dystonia including generalized and segmental dystonia, hemidystonia, and cervical dystonia. It is indicated for individuals 7 years of age or older as an aid in the management of chronic dystonia when symptoms of the disease are not adequately controlled by medications. The effectiveness of this device for this use has not been demonstrated. (Visit the FAQ section for more information about Humanitarian Device Exemptions.) To find out if Activa DBS may be right for you, ask your neurologist for an evaluation.
