CE mark approval for the first deep brain stimulation visualisation system


Boston Scientific has received CE mark approval for use of the Guide deep brain stimulation system which, according to the company, is the world’s first deep brain stimulation visualisation system. Guide provides clinicians with 3D visualisation information that simulates stimulation output, which could reduce programming time and enable more precise targeting of therapy. Guide, according to a company press release, enables physicians to visualise the relative position of lead location and utilise stimulation field models within the brain.

“Guide deep brain stimulation is an important tool for advancing deep brain stimulation,” said Jens Volkmann, director of the Department of Neurology at the University Clinic Wurzburg in Germany. “The visualisation of the stimulation fields is designed to improve therapy because physicians may take advantage of the unique programming options of the Vercise deep brain stimulation system.”

The Guide technology, combined with the Vercise deep brain stimulation system, was developed, according to the company, to provide advanced deep brain stimulation technology to neurologists, neurosurgeons and their patients. By visualising the stimulation options of the Vercise deep brain stimulation system, clinicians could provide tailored stimulation therapy to help meet patient needs.

It is the first commercial product resulting from the Boston Scientific acquisition of Intelect Medical in 2011.

“Guide deep brain stimulation is a groundbreaking technology,” said Maulik Nanavaty, president of the Boston Scientific Neuromodulation division. “This innovative system is the first of its kind and designed to help physicians provide better therapy for their patients and improve programming time.”

Guide deep brain stimulation and the Vercise deep brain stimulation system are both CE marked for the treatment of Parkinson’s disease. The Vercise system was approved for sale in Europe in 2012. 

In the USA, Guide and Vercise systems are investigational and not available for sale.