Medtronic Wins FDA Approval for Expanded Deep Brain Stimulation Labeling for Dystonia

Reuters12-04 22:17
Medtronic Wins FDA Approval for Expanded Deep Brain Stimulation Labeling for Dystonia

Medtronic plc has received U.S. Food and Drug Administration (FDA) approval for expanded clinical labeling of its Deep Brain Stimulation $(DBS)$ system for the treatment of dystonia. This approval transitions the therapy from Humanitarian Device Exemption (HDE) status to full effectiveness labeling, supported by clinical evidence. The expanded labeling covers the management of chronic, intractable primary dystonia-including generalized, segmental, and cervical dystonia-for adults and primary generalized dystonia in patients aged 12 or older. This milestone provides stronger evidence, clearer treatment pathways, and improved access for patients and clinicians.

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