In 2003, Medtronic first received a humanitarian green light from the FDA to offer its deep brain stimulation implants to treat the symptoms of dystonia—the painful movement disorder that can cause abnormal posture and involuntary muscle spasms.
Officially known as a humanitarian device exemption, it’s a tool infrequently used by the agency for therapies aimed at rare diseases—with fewer than 60 new applications granted in the 22 years that have followed. It excuses developers from the requirements to prove their systems’ effectiveness, while setting restrictions on how much profit can be made from their sale.
Medtronic’s deep brain stimulators have dramatically evolved in those past two decades—with advancements in battery life and rechargeability, size, MRI safety and the ability to adapt to the body’s response to therapy—and the company’s regulatory listing has kept pace with the times, being updated on nearly 400 occasions.
Now, the medtech giant has claimed a full FDA approval, saying it finally has the evidence to back up its approach. Medtronic said that makes its systems the first and only stimulators to carry a label in the U.S. for dystonia.
“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,” Ashwini Sharan, M.D., chief medical officer of Medtronic’s neuromodulation division, said in a statement.
The company characterizes dystonia as the third most-common movement disorder in the U.S., affecting as many as 250,000 people, with no available cures or disease-modifying treatments.
The FDA’s new labeling includes the management of chronic, intractable primary dystonia, including generalized dystonia, segmental dystonia of the head and neck, and cervical spine dystonia for adults, as well as primary generalized dystonia in patients age 12 and up.
Medtronic said its deep brain stimulation implants have helped treat more than 200,000 patients with movement disorders and other conditions in more than 70 countries since their debut in 1987. In the U.S., they carry approvals for Parkinson's disease, essential tremor and epilepsy—plus another humanitarian exemption for obsessive-compulsive disorder, issued in 2009.