St Jude Medicals Deep Brain Stimulation Trifecta: New Treatment Options for Dystonia in EU
ByKimberly GuilliottiApril 23, 2013
St Jude Medical recently announced on April 10th that they received the European CE mark of approval on three deep brain stimulation (DBS) systems for the treatment of Dystonia symptoms. The Libra, LibraXP, and Brio systems are the first to gain approval from a regulatory agency for use in the treatment of symptoms from primary and secondary Dystonia. Currently there are no clinical trials ongoing for FDA approval that might indicate when the US market can expect to see St Judes DBS.Dystonia is a neurological movement disorder which causes involuntary muscle spasms and contractions. These contractions and spasms can cause painful twisting and repetitive movements and distort the body into irregular postures. Dystonia that is genetic or idiopathic in origin is classified as Primary Dystonia. Secondary Dystonia is classified as Dystonia caused by trauma, drug exposure, or another disease such as infection, stroke, metabolic condition, or tumor. The American Dystonia Society estimates 300,000 people in the U.S. have been diagnosed or are awaiting proper diagnosis of Dystonia.Dystonia is typically treated with a combination of physical therapy, drug therapy, and surgery. Oral medications include anticholenergics, dopaminergics, baclofen, benzodiazepines, and tetrabenzenes. Injections of botulinum neurotoxin can also be used to reduce excessive muscle contractions in certain muscle groups. Surgical treatment for those who do not respond to oral medication or injections can include peripheral denervation, intrathecal baclofen delivery, brain lesioning, and deep brain stimulation.DBS therapy for dystonia involves the delivery of mild electrical pulses to a specific target in the brain. The main focus for DBS treatment has been the Globus pallidus (GPi), which is a sub-cortical structure within the brain. DBS treatment in this area has shown to be effective in patients with generalized dystonia, segmental dystonia, cervical dystonia, and many others. There have also been favorable results with DBS treatment in the ventral intermedius nucleus of the thalamus.Medtronic currently has a DBS system available for use in the U.S. The Activa GPi System has a Humanitarian Device Exemption (HDE), gaining approval without a formal clinical trial due to the small number of people Dystonia affects, for treatment of primary Dystonia, and is currently enrolling patients with primary Dystonia in clinical trials.
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