Boston Scientific’s system works by stimulating a region of the brain through implanted nodes, which are powered by an implantable pulse generator. The system is supposed to help improve or lessen motor function deterioration.
Thee approval came following the results of a randomized, double-blind study in the U.S., which evaluated and confirmed the safety and efficacy of the system in 292 patients across 23 sites. In addition, the safety data from a European study found that 40 patients that used the system demonstrated a 63 percent improvement in motor function after a year from their baseline as measured by a Parkinson’s disease rating scale.
The first stimulation system implantation in the U.S. will take place at Minneapolis-based University of Minnesota Medical Center.
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