(Reuters) - St. Jude Medical Inc said on Wednesday it received European regulatory approval for a brain implant to treat an incurable neurological disorder that can leave its victims wheelchair-bound.
The maker of heart pacemakers, valves and other medical devices said European regulators approved its Brio, Libra and LibraXP deep brain stimulation systems for managing symptoms of primary and secondary Dystonia.
Dystonia causes a person's muscles to involuntarily contract and spasm. For those who do not respond to medication, deep brain stimulation may help alleviate symptoms, such as repetitive, twisting movements.
The device works by delivering electrical pulses to specific areas of the brain involved in controlling movement.
Dystonia is thought to affect more than 500,000 people in Europe.
Primary Dystonia may be genetically inherited; the origin of the disorder is unknown. Secondary Dystonia is considered environmental or symptomatic. It may result from a condition such as a stroke, or from certain medications.
Deep brain stimulation has been used to manage the symptoms of Parkinson`s disease for more than 15 years. Medtronic Inc was the first company to develop and market the technology, which also has been approved to treat Essential Tremor and some psychiatric disorders.
To implant the device, which is about the size of the face of a man's wristwatch, a neurosurgeon places two thin leads with small electrodes into a specific area in the brain - the subthalamic nucleus or the globus pallidus interna. Both areas are involved with controlling movement.
The leads are then connected to a power source that is placed just under the skin, near the pectoral muscle in the chest, delivering a constant series of painless electrical pulses.
The system is programmed specifically for each patient and can be adjusted as symptoms change or as the disease progresses.
The therapy does not destroy or remove any part of the brain, like other surgical treatments used for movement disorders.
Shares of St. Jude were up 0.3 percent at $41.33 in early trading.
(Reporting by Debra Sherman; Editing by Gerald E. McCormick, Bernadette Baum and Lisa Von Ahn)