Vercise deep brain stimulation system receives CE mark approval for dystonia

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The Vercise deep brain stimulation system (Boston Scientific) has received CE mark approval for the treatment of intractable primary and secondary dystonia.

According to a press release, 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 system is the first system designed to selectively stimulate targeted areas of the brain in order to customise therapy and manage symptoms of Parkinson’s disease, the company states.

The first implant of the Vercise system for the treatment of dystonia was performed by a team from the Charité Campus Virchow-Klinikum (CVK), Berlin, Germany, which included Andrea Kühn, Department of Neurology, and 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 system represents advancement in dystonia care by providing more flexible and unique programming options for targeted deep brain stimulation tailored to each individual,” says Kühn.  

“The device itself is designed to offer additional patient benefits including the longest battery life available for deep brain stimulation and the smallest implanted stimulator footprint, especially important for our young patients,” comments Schneider.

“The Vercise 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 multicentre clinical trial,” notes 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 deep brain stimulation system received CE mark and Australia Therapeutic Goods Administration (TGA) approval in 2012 for the treatment of Parkinson’s disease. It is available in Europe, Israel, Australia and Colombia for such treatment. In the USA, the Vercise system is investigational and not available for use or sale.