Clinical Data
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