Boston Scientific system receives CE Mark approval for Dystonia
The Boston Scientific Vercise Deep Brain Stimulation (DBS) System has received CE Mark approval for the treatment of intractable primary and secondary dystonia, a neurological movement disorder characterized by involuntary muscle contractions.
Dystonia affects more than 500,000 people across Europe, including children and adults. It is the third most common movement disorder after Parkinson's disease and essential tremor. Symptoms include involuntary muscle contractions, with twisting, repetitive movements or abnormal postures, which can be painful and debilitating. The Vercise DBS System is the first system designed to selectively stimulate targeted areas of the brain in order to customize therapy and manage symptoms of Parkinson's disease. This system now offers new hope for patients with dystonia.
The first implant of the Vercise DBS System for the treatment of dystonia was performed by a team from the Charité Campus Virchow-Klinikum (CVK), which included prof. Dr. Andrea Kühn, department of neurology, and Dr. Gerd-Helge Schneider, department of functional neurosurgery.
"Historically, treatment of secondary dystonia has been challenging and efficacy was typically incomplete and partially limited by side effects. The Vercise DBS system represents an advancement in dystonia care by providing more flexible and unique programming options for targeted deep brain stimulation tailored to each individual," said Kühn.
"The device itself is designed to offer additional patient benefits including the longest battery life available for DBS and the smallest implanted stimulator footprint, especially important for our young patients," said Schneider.
"The Vercise DBS System's advanced technology has already demonstrated significant improvements in motor scores for patients with Parkinson's disease as evidenced by the interim results from our VANTAGE multicenter clinical trial," said Maulik Nanavaty, president, Neuromodulation, Boston Scientific. "With this approval we look forward to extending the use of this technology to improve the quality of life of patients with dystonia."
The Vercise DBS System received CE Mark and Australia TGA (Therapeutic Goods Administration) approval in 2012 for the treatment of Parkinson's disease. It is available in Europe, Israel, Australia and Colombia for such treatment. In the U.S., the Vercise DBS System is investigational and not available for use or sale.