FDA Approves Expanded Indication of Focused Ultrasound for Parkinson Disease Motor Symptoms

The Food and Drug Administration (FDA) has approved focused ultrasound (Exablate Neuro; Insightec, Miami, FL) for treating individuals with drug-refractory Parkinson disease (PD) with mobility, rigidity, or dyskinesia symptoms. Focused ultrasound is used to ablate the globus pallidus (GPi) noninvasively.

"Movement disorder neurologists now can offer their Parkinson's patients a less invasive surgical option as part of their treatment plan," Paul S. Fishman, MD, PhD, professor of neurology, pharmacology and neurobiology at the University of Maryland School of Medicine.

"This approval is significant in that it adds Focused Ultrasound as an incisionless surgical option to treat motor symptoms of Parkinson disease," added Howard M. Eisenberg, MD, RK Thompson professor, Department of Neurosurgery at the University of Maryland and Principal Investigator.

Focused ultrasound received approval from the FDA for medication-refractory essential tremor in 2016 and tremor-dominantPD in 2018. There are 37 medical centers in the US providing focused ultrasound treatment.