CE Mark For Boston Scientific’s GUIDE™ DBS System

Boston Scientific Corporation has gained CE Mark approval for use of the GUIDE™ DBS System, the world’s first deep brain stimulation (DBS) visualization system. GUIDE DBS provides clinicians with 3D visualization information that simulates stimulation output, which the company says may reduce programming time and enable more precise targeting of therapy. With GUIDE DBS, physicians are able to visualize the relative position of lead location and utilize stimulation field models within the brain.

Background

Boston Scientific is an innovation leader in implantable DBS technology. Approved for sale in Europe in 2012, the Vercise DBS System is the first and only DBS system commercially available to incorporate multiple independent current control, which is designed to selectively stimulate targeted areas in the brain.

GUIDE DBS technology, when combined with the Vercise DBS System, was developed to provide the most advanced deep brain stimulation technology to neurologists, neurosurgeons and their patients. By visualizing the advanced stimulation options of the Vercise DBS System, clinicians can provide more tailored stimulation therapy to help meet patient needs.

GUIDE DBS is based on more than a decade of research and science validated in more than 30 peer-reviewed publications. It is the first commercial product resulting from the Boston Scientific acquisition of Intelect Medical in 2011.

Physician comments

“GUIDE DBS is an important tool for advancing DBS,” said Prof. Dr. Jens Volkmann, director of the Department of Neurology at the University Clinic Wurzburg in Germany. “The visualization of the stimulation fields is designed to improve therapy because physicians may take advantage of the unique programming options of the Vercise™ DBS System.”

Company comments

“GUIDE DBS 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.”

Regulatory status

GUIDE DBS and the Vercise DBS System are CE Marked for the treatment of Parkinson’s disease.

In the U.S., the GUIDE DBS and Vercise DBS Systems are investigational and not available for sale.

Source: Boston Scientific Corporation, PR Newswire