The Food and Drug Administration (FDA) has given an expanded indication for a deep brain stimulation (DBS) system (Infinity DBS; Abbott, Abbott Park, IL) that targets the internal globus pallidus (GPi) to improve symptoms of Parkinson’s disease that are not adequately controlled by medication.
The system is now approved for all major targets used to treat movement disorders, Parkinson's disease, and Essential Tremor: the subthalamic nucleus (STN), ventral intermediate nucleus (VIM), and GPi.
The system operates on an iOS software platform with Bluetooth wireless technology. Clinicians can streamline the programming process with an iPad Mini device and patients can discreetly manage their symptoms with an iPod Touch controller.
"The internal segment of the global pallidus, or GPi, is a well-established, valuable DBS target for the management of the motor signs associated with Parkinson's disease, and is a preferred target for many patients, particularly for those with troublesome medication-induced dyskinesia," said Jerrold Vitek, MD, PhD, head of the Neurology Department, director of the Neuromodulation Research Program, and center director of the University of Minnesota Udall Center of Excellence for Parkinson's Research. "This approval expands the options for patients to tailor treatment to their unique needs, with the added benefits of being able to target precise areas and utilize a patient-friendly iOS device."
The expanded indication is supported by data from the PROGRESS study (NCT02989610).
"Abbott's PROGRESS study has led the way in establishing the value of directional DBS systems for targeted areas of the brain," said Binith Cheeran, MD, director of medical affairs, deep brain stimulation, Abbott. "The approval of Abbott's Infinity DBS system with targeted stimulation is a significant advancement for people living with Parkinson's disease and their care teams. The ability to optimize the programming for each individual opens the door for a new standard of care for DBS therapy."
Daniel S. Reich, MD, PhD
Konstantin Balashov, MD, PhD
Michael V. Robers, MD, Deepak Soneji, MD, PhD, and Lilyana Amezcua, MD, MS