St. Jude Medical Gets CE Mark for Deep Brain Stimulation Device to Treat Dystonia
St. Jude Medical announced Wednesday that the company has received CE Mark to market its deep brain stimulation devices for both primary and secondary dystonia.
April 10, 2013
St. Jude Medical announced Wednesday that the company has received CE Mark clearance for its deep brain stimulation device for sale in Europe to treat patients with both types of dystonia.
Brio, Libra and the Libra XP can now be used to treat primary and secondary dystonia.
St. Jude Medical's Deep Brain Stimulation Devices |
"Dystonia strikes people of all ages including children and young adults, often leaving them disabled and sometimes wheelchair-bound,” said Elena Moro, professor of neurology at the University Hospital Center of Grenoble, France, said in a St. Jude news release. “For patients who do not respond to medications, deep brain stimulation therapy may alleviate symptoms such as repetitive, twisting movements, allowing them to improve their independence and overall quality of life.”
Deep Brain Stimulation (DBS) belongs under the umbrella of neurostimulation where electrical impulses are delivered to a particular nerve or cells in the body. The International Society of Neuromodulation dates the therapy back to 1997 when the FDA first approved it to treat essential tremor. It is now used to treat conditions like Parkinson's Disease, epilepsy and dystonia.
However, St. Jude Medical's DBS devices represents the first instance when a regulatory body cleared them to treat both primary and secondary dystonia.
"“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, president of the St. Jude Medical Implantable Electronic Systems Division, in the news release. “This approval represents a significant milestone for St. Jude Medical as we continue to develop therapies to treat a broad range of neurological conditions.”
The global market for neuromodulation is estimated to grow to $6.8 billion by 2017, according to a report from Markets and Markets.
By Arundhati Parmar, Senior Editor, MD+DI
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