MARLBOROUGH, Mass., Dec. 11, 2017 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the Vercise™ Deep Brain Stimulation (DBS) System. DBS is used to treat the symptoms of Parkinson's disease (PD), a degenerative condition that affects more than one million people in the United States and 10 million worldwide.1 DBS works by stimulating a targeted region of the brain through implanted leads that are powered by a device called an implantable pulse generator (IPG).

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The approval was based on the INTREPID study, the first multi-center, prospective, double-blind, randomized sham-controlled study of DBS for PD in the U.S. The INTREPID study evaluated the safety of the system in 292 patients at 23 sites and also evaluated its effectiveness. It successfully met its primary endpoint of mean change in waking hours with good symptom control (n=160). Data from the INTREPID study is expected to be released in 2018. The filing was also supported by safety data from the European multi-center, prospective, single-arm VANTAGE study. In the VANTAGE study, 40 patients treated with the Vercise DBS System demonstrated a 63 percent improvement in motor function at 52 weeks from baseline as measured by the Unified Parkinson's Disease Rating Scale III, as well as improvements in quality of life and medication usage.2

Following FDA approval, the first commercial implant in the U.S. with the Vercise System will take place at the University of Minnesota Medical Center in Minneapolis, MN by faculty physicians from the University of Minnesota Medical School including Jerry Vitek, M.D., Ph.D, professor and chair, Department of Neurology, Michael C. Park, M.D., Ph.D, assistant professor, Department of Neurosurgery and Lauren E. Schrock, M.D., MnDrive neuromodulation faculty scholar, Department of Neurology.

"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."

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