Boston Scientific Corp (NYSE:BSX) has obtained approval from the U.S. FDA for the Vercise™ DBS System. Deep Brain Stimulation is used to treat the indications of Parkinson’s disease, a degenerative condition that impacts over one million people in the U.S. and 10 million globally. It works by stimulating an intended region of the brain via implanted leads that are supported by a device named implantable pulse generator.
The details
The approval was grounded on the INTREPID trial, the first multi-center, double-blind, prospective, randomized sham-controlled trial of Deep Brain Stimulation for Parkinson’s Disease in the United States. The INTREPID trial assessed the safety of the system in 292 subjects at 23 sites and also assessed its effectiveness.
It successfully achieved its primary objective of mean change in waking hours with promising symptom control. Report from the INTREPID trial is projected to be posted in 2018. The submission was also supported by safety report from the European multi-center, potential, single-arm VANTAGE trial. In the VANTAGE trial, 40 subjects treated with the Vercise Deep Brain Stimulation System showcased a 63% improvement in motor function at 52-weeks from baseline as computed by the Unified PD’s Rating Scale III, and improvements in medication usage and quality of life.
Following FDA go-ahead, the preliminary commercial implant in the United States with the Vercise System will occur at the University of Minnesota Medical Center by faculty physicians including Jerry Vitek, M.D., Ph.D, Michael C. Park, M.D., Ph.D, and Lauren E. Schrock, M.D.
Dr. Vitek, the Coordinating Principal Investigator for the respective trial, reported that the Vercise DBS System alters the scope of what physicians can perform to help enhance the quality of life for people struggling with Parkinson’s disease. This system offers an ability to sculpt the existing field in the DBS target utilizing unique technology that provides flexibility in programming. This flexibility enables them to target distinct areas of the subthalamic nucleus, which they consider will improve results while lowering side effects.