The U.S. Food and Drug Administration approved Boston Scientific Corp.'s Vercise Deep Brain Stimulation System to treat symptoms of Parkinson's disease.
Parkinson's disease is a degenerative condition that affects more than 1 million people in the U.S. and 10 million worldwide.
Approval for the deep brain stimulation device was based on the company's successful INTREPID study, which met its primary endpoint of mean change in waking hours with good symptom control. Data from the study is expected to be released in 2018.
The filing was also supported by safety data from the VANTAGE study, in which the system demonstrated a 63% improvement in motor function at 52 weeks from baseline, as well as improvements in quality of life and medication usage.
