After 22 years, Medtronic's DBS gains full FDA approval for dystonia
Deep brain stimulation for dystonia moves from humanitarian exemption to full effectiveness labeling, including patients 12 and older.
Medtronic has received FDA approval of expanded labeling for its deep brain stimulation systems in dystonia, a movement disorder that causes involuntary muscle contractions. Since 2003, DBS for dystonia had been available only under a Humanitarian Device Exemption, which requires proof of safety but not effectiveness. The new label is backed by clinical effectiveness evidence and covers several forms of primary dystonia in adults, and primary generalized dystonia in patients aged 12 and older.
Full approval can simplify access and insurance coverage for a long-used therapy.
Learn more: Deep brain stimulation · Medtronic