Boston Scientific Corporation has announced that it has received approval from the US Food and Drug Administration (FDA) for the Vercise Deep Brain Stimulation (DBS) System. DBS is used to treat the symptoms of Parkinson disease (PD), a degenerative condition that affects more than 1 million people in the US and 10 million worldwide. 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). 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 US. The INTREPID study evaluated the safety of the system in 292 patients at 23 sites and also evaluated its effectiveness.
Boston Scientific is headquartered in Marlborough, MA.
Boston Scientific receives US FDA approval for the Vercise™ Deep Brain Stimulation System. Platform offers physicians advanced technology to treat symptoms of Parkinson's disease. [news release]. Marlborough, MA: Boston Scientific Corporation. December 11, 2017. http://news.bostonscientific.com/2017-12-11-Boston-Scientific-Receives-U-S-FDA-Approval-for-the-Vercise-TM-Deep-Brain-Stimulation-System. Accessed January 2, 2018.
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