The European Union has granted CE mark certification to St. Jude Medical's deep brain stimulation (DBS) systems, designed for the treatment of primary and secondary dystonia, a neurological movement disorder.
The devices, Brio, Libra and LibraXP, are placed using two thin leads with small electrodes that are connected to a power source placed just under the skin near the pectoral muscle in the chest.
The DBS therapy delivers a constant series of painless electrical pulses to the specific target regions including the subthalamic nucleus (STN) or the globus pallidus interna (GPi) of the brain, which are involved with controlling movement.
Brio, which the company claims to be the world's smallest DBS device, has a thin 10mm profile and greater implant depth, making the device suitable for patients with a small body type.
France University Hospital Centre neurology professor Dr Elena Moro said dystonia strikes people of all ages, including children and young adults, often leaving them disabled and sometimes wheelchair-bound.
"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," Moro said.
St. Jude Medical implantable electronic systems division president Dr Eric Fain said; "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."
The DBS therapy, which is available in Europe and Australia for the treatment of Parkinson's disease, is being clinically evaluated for use in depression and essential tremor.
St. Jude said the DBS systems are not approved for use in the US.
Image: St. Jude's deep brain stimulation systems treats both primary and secondary dystonia. Photo: Courtesy of St. Jude Medical.