System Includes First Directional Lead with Current Steering and
Expanded Programming Flexibility
MARLBOROUGH, Massachusetts,
Sept. 10, 2015 /PRNewswire/ -- 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.
About Boston Scientific
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for more than 35 years, we advance science for life by providing a
broad range of high performance solutions that address unmet
patient needs and reduce the cost of healthcare. For more
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