The Food and Drug Administration (FDA) has approved the Vercise Deep Brain Stimulation (DBS) System (Boston Scientific) to treat the symptoms of Parkinson disease (PD).
The system, which was developed from a foundation of cochlear implant technology, stimulates a targeted region of the brain through implanted leads that are powered by an implantable pulse generator.
The FDA’s approval was based on results from the INTREPID study, which included 292 patients at 23 sites. The study was the first multi-center, prospective, double-blind, randomized sham-controlled study of DBS for Parkinson’s disease in the US.
The trial met its primary endpoint of mean change in waking hours with good symptom control (n = 160). Full data from the study is expected to be presented sometime in 2018.
The Vercise System allows clinicians greater control to deliver a prescribed amount of therapy to target different regions of the brain, as well as regulation of the flow of stimulation to enable patient-specific programming. “This system provides an ability to sculpt the current field in the DBS target using novel technology that offers flexibility in programming,” said Jerry Vitek, MD, PhD, Department of Neurology, University of Minnesota — where the first commercial implant of the system will be conducted. “This flexibility allows us to target different regions of the subthalamic nucleus, which we believe will improve outcomes while reducing side effects.”
Boston scientific receives US FDA approval for the Vercise™ deep brain stimulation system [press release]. Marlborough, MA: Boston Scientific. Published December 11, 2017, 2017. Accessed December 13, 2017.
This article originally appeared on MPR