The Food and Drug Administration (FDA) has expanded the approval of Exablate® Neuro to include treatment of medication-refractory Parkinson disease patients with moderate to severe motor complications.
Using MRI-guided focused ultrasound, the device is able to perform a noninvasive pallidotomy, targeting and ablating the globus pallidus. Exablate Neuro was previously approved for the treatment of medication-refractory essential tremor and for tremor-dominant Parkinson disease.
The expanded approval was based on data from a 2-arm, sham-controlled, randomized, multicenter study (ClinicalTrials.gov Identifier: NCT03319485) that evaluated the treatment in 92 patients with medication-refractory, advanced idiopathic Parkinson disease.
“This approval is significant in that it adds focused ultrasound as an incisionless surgical option to treat motor symptoms of Parkinson disease,” said Howard M. Eisenberg, MD, R.K. Thompson Professor, Department of Neurosurgery at the University of Maryland and Principal Investigator.
Insightec announces FDA approval of Exablate Neuro for the treatment of Parkinson’s disease. News release. Insightec. Accessed November 3, 2021. https://www.prnewswire.com/news-releases/insightec-announces-fda-approval-of-exablate-neuro-for-the-treatment-of-parkinsons-disease-301414996.html.