FDA approves innovative, U-tested Parkinson’s device
Options for patients with Parkinson’s disease have just expanded. The Food and Drug Administration has approved the Vercise Deep Brain Stimulation (DBS) System, a device developed by Boston Scientific Corp. that treats symptoms of the disease. Vercise’s safety and efficacy were confirmed in a clinical trial led by Dr. Jerrold Vitek, professor and chair of the University of Minnesota Department of Neurology, and Dr. Philip Starr of the University of California, San Francisco.
The FDA approval extends the availability of the device to Parkinson’s patients outside the clinical trial and makes it available to them through standard medical plans. According to the Parkinson’s Foundation, the disease affects an estimated one million people in the United States and 10 million worldwide, and costs an estimated $25 billion in the United States alone.
The Vercise DBS system is based on an electrical lead that is inserted in the brain and must be precisely positioned to reach a target area smaller than a pea. Once in place, electrodes on the lead deliver electrical current to brain cells to correct tremors and other symptoms of Parkinson’s. Each electrode can be independently programmed to deliver current at a precise strength and location in the target area—a feature that allows great flexibility, precision, and control.
Recently, Vitek and his team successfully implanted the first patient outside of clinical trials with the Vercise DBS System at the University of Minnesota Medical Center.