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.
According to the Cleveland Clinic, dystonia could also be underdiagnosed.
Dystonia leads to involuntary muscle contractions that force certain parts of the body into repetitive, twisting movements or painful postures. These can interfere with everyday functions like walking, sleeping, eating and talking.
Medtronic said it has offered DBS for dystonia since 2003 as a humanitarian use device under HRDE. Expanded labeling enables the management of chronic, intractable primary dystonia. That includes generalized dystonia, segmental dystonia of the head and neck, and cervical dystonia for adults and for primary generalized dystonia in patients ages 12 or older.
The company delivers DBS through its Percept platform of neurostimulators. Percept now includes adaptive capabilities as well, delivering real-time, adaptive therapy through BrainSense technology.
“Medtronic DBS therapy provides people with dystonia a safe and effective non-destructive treatment that physicians can tailor with BrainSense technology, offering recharge and recharge-free options and the broadest conditional MRI access,” said Dr. Ashwini Sharan, chief medical officer, Medtronic Neuromodulation. “The clinical data show meaningful improvements in dystonia symptoms and quality of life in adult patients. DBS improved motor, disability, and severity scores across both groups, and reduced pain in adult patients — outcomes that can be truly life-changing.”
