Boston Scientific Gets CE Mark for Primary Cell Deep Brain Stimulation System

Marlborough, Mass.-based Boston Scientific has received the CE mark for its Vercise primary cell (PC) deep brain stimulation (DBS) system. The Vercise PC system is intended to provide precise neural targeting to address the varying needs of patients suffering from Parkinson’s disease (PD), primary and secondary dystonia, and essential tremor. The system is a non-rechargeable treatment option that also powers the Vercise DBS directional lead, which according to the company is the first commercially available eight-contact segmented lead with current steering.

The Vercise platform is designed to finely controls the size and shape of stimulation with multiple independent current control technology (MICC). The new directional lead with MICC produces multi-directional stimulation, which increases target efficiency. The system includes unique software solutions with a Clinical Effects Map (CEM) that captures data over time, visually summarizes the progress of individualized patient therapy, and enables physicians to monitor and modify treatment as needed. These features allow for programming flexibility, designed to enable better outcomes with fewer side effects.

“Managing the side effects of unwanted stimulation while delivering effective therapy is one of the biggest challenges of DBS,” said Jens Volkmann, M.D., Ph.D., director and chairman of the department of neurology, University Hospital of Würzburg in Germany. “The distinctive software solution of the new Vercise platform is straightforward yet intuitive and can help address this challenge.”

DBS therapy involves the placement of a device that stimulates specific areas in the brain using electrical signals. The Vercise PC system supplements the company’s rechargeable DBS device, a system with a 25-year battery life.

“The dual portfolio offering of a non-rechargeable system with current steering as well as a rechargeable system provides physicians and patients the ability to choose a platform that suits their needs while benefiting from the most advanced stimulation technology,” said Volker Coenen, M.D., Ph.D., medical director of Stereotactic and Functional Neurosurgery, University Medical Center Freiburg.

The portfolio is supported by a clinical program that includes the ongoing Intrepid clinical trial in the United States and the Vantage study in Europe.