Boston Scientific won FDA approval for its Vercise Deep Brain Stimulation System for treatment of Parkinson’s. The implantable stimulator can be programmed in a variety of ways to target different regions of the subthalamic nucleus. This may help to reduce the symptoms of Parkinson’s by delivering therapy in an optimal way for each patient.
The implant is rechargeable and can last for more than 15 years. Each of the eight electrodes on the leads can be controlled independently. The electrodes make contact with brain tissue along a 15.5 millimeter length, meaning they’re separated by only .5 millimeters.
The technology has already been available in Europe for the last five years.
Here’s some information on the trials that led to the approval, according to Boston Scientific:
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.
Flashbacks: Vercise Gevia Deep Brain Stimulation System with Visual Brain Targeting Software Cleared in Europe…; Boston Scientific’s Vercise Deep Brain Stimulator Gets Expanded Indication in Europe for Dystonia…; Vercise Deep Brain Neurostimulator EU Approved for Tremor (VIDEO)…; Boston Sci’s Vercise DBS for Parkinson’s Cleared in EU…
Via: Boston Scientific…