FDA Expands Approval of MRI-Guided Ultrasound Treatment for Patients with Parkinson’s Disease
For patients with advanced Parkinson’s disease, the expanded FDA approval of the Exablate Neuro platform allows for the use of MRI-guided focused ultrasound in performing staged bilateral pallidothalamic tractotomy.
The Food and Drug Administration (FDA) has granted an expanded approval for Exablate Neuro, which utilizes MRI-guided ultrasound treatment, in staged bilateral pallidothalamic tractotomy procedures for patients with advanced Parkinson’s disease.
Insightec, the manufacturer of Exablate Neuro, said the expanded approval provides targeted ultrasound treatment of the pallidothalamic tract and a viable alternative for patients with Parkinson’s disease-related dyskinesia, bradykinesia and rigidity.
“This new indication represents a significant step forward in how integrated movement disorder teams will approach the treatment of Parkinson's disease," noted Michael Kaplitt, M.D., who is affiliated with the Department of Neurological Surgery at Weill Cornell Medicine-New York Presbyterian Hospital. "As the lead investigator of the clinical trial evaluating the safety and effectiveness of the staged bilateral procedure with the Exablate system, I'm encouraged by the results and am excited about what it offers my patients."
Results from the aforementioned multicenter multinational clinical trial assessing Exablate Neuro in staged bilateral pallidothalamic tractotomy procedures for Parkinson’s disease will be published later in 2025, according to Insightec.
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