US-based Boston Scientific has obtained CE Mark approval for its Vercise deep brain stimulation (DBS) system for the treatment of intractable primary and secondary dystonia.
Dystonia is a neurological movement disorder characterized by involuntary muscle contractions.
The first implant of the Vercise DBS system for the treatment of dystonia was performed by a team from the Charite Campus Virchow-Klinikum.
Boston Scientific Neuromodulation president Maulik Nanavaty noted 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.
"With this approval we look forward to extending the use of this technology to improve the quality of life of patients with dystonia," Nanavaty added.
Boston Scientific has obtained CE Mark approval and Australia Therapeutic Goods Administration clearance in 2012 for the treatment of Parkinson’s disease.
According to the company, Vercise DBS system is the first system that will selectively stimulate targeted areas of the brain in order to customize therapy and manage symptoms of Parkinson’s disease.
The device is available in Europe, Israel, Australia and Colombia for the treatment of Parkinson’s disease.
It is an investigational device in the US and is not available for use or sale in the country.