St. Jude Medical received European regulatory approval to offer its Brio, Libra and LibraXP deep brain stimulation (DBS) systems as therapy options for addressing symptoms of intractable primary and secondary dystonia. Dystonia is a neurological disorder in which muscles contract involuntarily, binding sufferers’ limbs and causing awful, long lasting pain.
The implants stimulate the subthalamic nucleus (STN) or the globus pallidus interna (GPi) within the brain, regions of the brain responsible for motor control. The idea is to disrupt irregular signals produced within the brain and help liberate patients from symptoms of the disease.
From the announcement:
“This CE Mark is the first approval by a regulatory agency for the use of deep brain stimulation therapy to manage the symptoms of both primary and secondary dystonia, broadening the treatment options for patients in Europe whose lives are impacted by this disabling disease,” said Eric S. Fain, M.D., president of the St. Jude Medical Implantable Electronic Systems Division. “This approval represents a significant milestone for St. Jude Medical as we continue to develop therapies to treat a broad range of neurological conditions.”
Dystonia is an incurable neurological movement disorder thought to affect more than 500,000 people across Europe. Primary dystonia is defined as an illness in which the origin of the disease is unknown, and may be genetically inherited. Secondary dystonia is considered environmental or symptomatic as it often results from another condition such as a stroke, or as a response to certain medications such as dopamine blocking drugs used to treat psychiatric disorders. Onset of secondary dystonia can also result from an injury or trauma to the brain.