Boston Scientific Receives FDA Approval for the Vercise Deep Brain Stimulation System
Boston Scientific on December 11, 2017, received approval from the U.S. Food and Drug Administration (FDA) for the Vercise Deep Brain Stimulation (DBS) System. The device offers advance treatment for Parkinson’s disease.
Boston Scientific, Leading manufacturer of medical devices use DBS for treatment of Parkinson’s disease, which is operated by stimulating a targeted region of the brain through implanted leads powered by a device called an implantable pulse generator (IPG). Around one million people in the U.S. and more than and 10 million worldwide are affected by Parkinson’s disease. The first commercial implant for manufacturing of DBS will be set up in the U.S. at the University of Minnesota Medical Center in Minneapolis by faculty physicians from the University.
According to Deep Brain Stimulation Device Market report published by Coherent Market Insights, DBS device can be used on patient’s suffering from major complications of Parkinson’s disease for four years and more. Although there are other surgical options available such as thalamotomy and pallidotomy, deep brain stimulation is the most preferred option, as it does not involve tissue destruction and is a reversible surgical treatment.
The approval of the device was based on the Implantable Neurostimulator for the Treatment of Parkinson’s Disease (INTREPID) study. The study evaluated the safety and effectiveness of the system in 292 patients across 23 sites. The Vercise System is capable of controlling the amount of current delivered by each of the electrodes on the implanted leads. The System leads have eight contacts with a long total span of 15.5mm, tight spacing between each contact of .5mm, and multi-lumen construction. These system features are designed to work together to address common challenges in DBS therapy such as fluctuations in symptoms and the progressive nature of the condition by offering more adaptable delivery of stimulation.
“The Vercise DBS System changes the landscape of what physicians can do to help improve the quality of life for people living with Parkinson’s disease,” said Dr. Vitek, coordinating principal investigator for the INTREPID study. “This system provides an ability to sculpt the current field in the DBS target using novel technology that offers flexibility in programming. This flexibility allows us to target different regions of the subthalamic nucleus, which we believe will improve outcomes while reducing side effects.”
The Vercise System was launched in Europe in 2012 by a foundation of cochlear implant technology, which was designed to specifically stimulate auditory nerves to produce a sense of hearing. The Vercise IPG is the smallest rechargeable DBS device available in the U.S.
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