Medtronic’s Milestone Approval
Medtronic has received full approval from the U.S. Food and Drug Administration (FDA) for the use of its deep-brain stimulation (DBS) systems in dystonia. This follows the company’s earlier authorization in 2003, when it obtained a humanitarian device exemption that allowed the implants to be used to address the symptoms of the disorder. Dystonia is described as a painful movement condition that can lead to abnormal posture and involuntary muscle spasms.
Understanding the Humanitarian Device Exemption
The humanitarian device exemption is used by the FDA for therapies intended for rare diseases. According to the information provided, fewer than 60 new exemptions have been granted in the 22 years since Medtronic first received its designation. The pathway removes the requirement to prove effectiveness and also sets limits on how much profit can be made from the devices covered by the exemption.
Decades of Innovation Lead to Full Approval
Over the past two decades, Medtronic’s DBS systems have undergone a range of updates. The company reports improvements in battery life and rechargeability, device size, MRI safety, and the system’s ability to adjust to the body’s response to therapy. Medtronic’s regulatory listing has been revised nearly 400 times during this period. The company now states that it has produced evidence to support a full approval and says its devices are the first and only stimulators in the U.S. with labeling for dystonia.
Transformative Clinical Outcomes
Ashwini Sharan, M.D., chief medical officer of Medtronic’s neuromodulation division, said: “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.” Sharan also described dystonia as the third most common movement disorder in the U.S. and noted that it affects as many as 250,000 people, with no available cures or disease-modifying treatments.
Expanded FDA Labeling
The updated FDA labeling covers the management of chronic, intractable primary dystonia in adults. This includes generalized dystonia, segmental dystonia of the head and neck, and cervical spine dystonia. It also applies to primary generalized dystonia in patients aged 12 and older.
A Legacy of Neuromodulation
Medtronic reports that its DBS implants have been used since 1987 and have been employed in more than 200,000 patients with movement disorders and other conditions in over 70 countries. In the U.S., the devices are approved for Parkinson’s disease, essential tremor, and epilepsy, and they also hold a humanitarian exemption issued in 2009 for obsessive-compulsive disorder.
