INSIGHTEC has received approval from the US Food and Drug Administration (FDA) to initiate a pivotal study of the Exablate Neuro for treating dyskinesia symptoms or motor fluctuations of advanced Parkinson’s disease patients who have not responded to medication.
The study’s principal investigator is Howard Eisenberg, Professor of Neurosurgery, University of Maryland School of Medicine, and chair, Department of Neurosurgery, Raymond K Thompson, MD chair in Neurosurgery, University of Maryland Medical Center in Baltimore, USA.
Treatment of Parkinson’s disease patients with the Exablate Neuro is intended to improve motor function and reduce dyskinesia, one debilitating symptom that presents as uncontrolled, involuntary movement of the arms and/or legs.
Exablate Neuro uses focused ultrasound to target and ablate tissue deep in the brain with no surgical incisions. MR imaging guides the treatment planning and delivers thermal feedback for real-time monitoring. For Parkinson’s disease, the lesion is made in a portion of the globus pallidus (GPi), which is known to be involved in the regulation of voluntary movement.
Exablate Neuro became the first focused ultrasound device to receive FDA approval to treat medication-refractory essential tremor in July 2016. Today, there are more than 30 Exablate Neuro systems in 10 countries treating essential tremor patients.