Boston Scientific (NYSE: BSX) has received CE Mark for the 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, the first commercially available eight-contact segmented lead with current steering.
The Vercise platform is the only DBS solution that 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 novel 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 Prof. Dr. Jens Volkmann, director and chairman of the Department of Neurology, University Hospital of Würzburg. "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 an unparalleled 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 Prof. Dr. Volker Coenen, medical director of Stereotactic and Functional Neurosurgery, University Medical Center Freiburg.
The portfolio is supported by a robust clinical program including the ongoing INTREPID clinical trial in the United States and the VANTAGE Study in Europe. The VANTAGE Study demonstrated a highly significant and consistent improvement in motor scores as well as an increase in quality of life; the results were published in The Lancet Neurology last quarter.
"This new system exemplifies the Boston Scientific commitment to advancing DBS therapy and providing impactful and transformative technology to reach a broader range of patients suffering from these debilitating diseases," said Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific. "Our clinical evidence, unique software solution, and expanded portfolio, now with both rechargeable and non-rechargeable devices, enable physicians to provide their patients with a tailored solution."
The Vercise PC DBS System is not available for use or sale in the United States. The rechargeable Vercise DBS System is investigational in the U.S., currently being evaluated in the INTREPID Study.
Comparative statements true as of September 10, 2015.
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