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FDA Approves Innovative Parkinson’s Device Tested at U

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A new medical device designed to treat symptoms of Parkinson’s disease, tested in a clinical study led in part by a University of Minnesota neurologist, has received Food and Drug Administration approval to be used widely in patients.

The Vercise Deep Brain Stimulation (DBS) System, developed by med-tech company Boston Scientific, is a surgical implant that uses electric currents to stimulate precise areas within the brain to reduce involuntary shaking, bodily stiffness, and other symptoms of Parkinson’s. The U’s Dr. Jerrold Vitek, professor and chair of the Medical School’s Department of Neurology, and Dr. Philip Starr of the University of California led the multi-site “INTREPID” clinical study to help Boston Scientific confirm the Vercise system’s safety and effectiveness—a crucial step toward reaching FDA approval.

Parkinson’s affects more than 1 million people in the US and more than 10 million people worldwide, according to the Parkinson’s Foundation. With FDA approval, the Vercise device, which is designed to provide a longer battery life, better patient comfort, and more controlled and customizable stimulation for treating symptoms, will now be available to people with the disease through their standard medical care.

“It is very rewarding to see the research efforts of the INTREPID study come to fruition and be able to use this innovative technology for patient care,” Vitek said. “With the advent of new technology we are able to improve the quality of life for patients with Parkinson's disease. These are exciting times in the field of deep brain stimulation and for our neuromodulation team at the University of Minnesota.”

This month, Vitek and his team successfully implanted the first patient outside of clinical trials with the Vercise system at the University of Minnesota Medical Center.

Deep brain stimulation, the treatment technique harnessed by the Vercise system, is a central part of the U’s MnDRIVE Brain Conditions research area, which shares the goal of bringing innovative neuromodulation treatments to people with neurological disorders like Parkinson’s.

MnDRIVE Brain Conditions supported the INTREPID study in several ways. In addition to Vitek being a member of the Brain Conditions Steering Committee, several MnDRIVE Neuromodulation Scholars were involved in the trial, including Dr. Michael Park, Dr. Scott Cooper, and Dr. Lauren Schrock. What’s more, funding to MnDRIVE’s DBS Core helped support research staff that worked on the study’s Minnesota site.

For more on the U of M’s role in helping the Vercise DBS system reach FDA approval, see the story from KMSP-TV news.

Kevin Coss

Kevin Coss

Kevin is a communications specialist with the Office of the Vice President for Research.

coss@umn.edu

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