FDA Approves A Deep Brain Stimulation System for Parkinson’s As Safe for MRI

The Food and Drug Administration (FDA) has approved labeling a deep brain stimulator (DBS) for Parkinson’s disease (PD) (Vercise Gevia; Boston Scientific, Malborough, MA) as safe to use in a full-body 1.5 T MRI environment. The system will be labeled ImageReady. 

This DBS system is a second-generation device approved for treating tremor in people with Parkinson’s disease in January 2019. The first-generation device was approved for this indication in 2017. 

In the INTREPID study (NCT01839396) it was demonstrated that over 2 years, people treated with the system experienced a 48% improvement in motor function as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) III scores.  

"When evaluating which deep brain stimulation (DBS) system is best for each of my patients, I always consider the immediate and long-term needs my patient might have so that we can effectively address a patient's therapeutic needs even as their disease progresses," said Robert Gross, MD, PhD, MBNA Bowman Endowed Chair in Neurosurgery & Professor, Department of Neurosurgery at Emory University. "Customizable therapy, battery life, the size of the device, and access to MRI are factors patients should talk to their doctor about when they are considering DBS.”