FDA approves vercise deep brain stimulation system

 Boston Scientific Corporation announced that it has received approval from the U.S. Food and Drug Administration (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.

Following FDA approval, the first commercial implant in the U.S. with the Vercise System will take place at the University of Minnesota Medical Center in Minneapolis, MN by faculty physicians from the University of Minnesota Medical School including Jerry Vitek, M.D., Ph.D, professor and chair, Department of Neurology, Michael C. Park, M.D., Ph.D, assistant professor, Department of Neurosurgery and Lauren E. Schrock, M.D., MnDrive neuromodulation faculty scholar, Department of Neurology.  

The Vercise System first launched in Europe in 2012 and was developed from a foundation of cochlear implant technology, designed to specifically stimulate auditory nerves to produce a sense of hearing. The Vercise IPG is the smallest, rechargeable DBS device available in the U.S. and, depending on individual use, can have a battery life of more than 15 years.

"This approval marks an important step for patients who will now have the choice to be treated with one of the most innovative neuromodulation technologies available today," said Maulik Nanavaty, president and senior vice president, Neuromodulation, Boston Scientific. "Our system stands apart from the field in its approach and is changing the traditional definition on how we can leverage technology to treat patients with Parkinson's disease."