The medtech giant said the approval marks a shift from humanitarian device exemption (HDE) status to full effectiveness labeling. Backed by clinical evidence, the company’s DBS technology now extends to dystonia, a movement disorder.

In a news release, Medtronic said Dystonia represents the third-most common movement disorder in the U.S. According to the American Association of Neurological Surgeons, it affects as many as 250,000 people in the U.S. Medtronic says no treatment exists to reverse the course of the disorder.