Step forward in use of DBS System to treat Parkinson's disease

Boston Scientific Corporation announced that it has received approval from the 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.

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 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.

Comment: The Vercise Deep Brain Stimulation (DBS) System. has a CE Mark and was first launched in Europe in 2012.