Boston Scientific wins FDA nod for Vercise DBS for treating Parkinson ’ s disease

Boston Scientific (NYSE:BSX) said yesterday it won FDA approval for its Vercise deep brain stimulation system designed to treat symptoms of Parkinson’s disease. The device, initially launched in Europe in 2012, was developed based on cochlear implant technology and is designed to stimulate a targeted region of the brain through implanted leads powered by an implantable pulse generator.  The device also has the ability to independently control the amount of current delivered on each lead, the company said. “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. 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,” neuromod prez Maulik Nanavaty said in a press release. Approval of the device came based on data from the Intrepid study of the device which evaluated the use of the system in 292 patients across 23 sites. The trial met its primary endpoint of mean change in waking hours with good symptom control, and  full data from the trial is expected to be released next year. FDA approval was also supported by safety data from the Vantage study of the device, in which 40 patients treated with the Vercise DBS were shown to have a 63% improvement in motor function at 1 year from baseline as measured by the United Par...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance Boston Scientific Source Type: news