The Food and Drug Administration (FDA) has approved InSightec’s ExAblate Neuro, the first focused ultrasound device for the treatment of essential tremor in patients who have not responded to medication.
Using MRI-guided focused ultrasound, the device is able to perform a non-invasive thalamotomy, destroying the tissue in the thalamus thought to be responsible for causing tremors. Essential tremor can be treated with beta-blockers or anticonvulsants but if the condition is not controlled with medication, it can also be treated with surgery or a deep brain stimulation device.
Prior to treatment with ExAblate Neuro, patients should first undergo MR and computerized tomography (CT) scans. Treatment involves the administration of transcranial focused ultrasound energy that increases in increments until patients experience less tremor. Patients are awake and responsive during the whole treatment duration.
The FDA approval was based on safety and efficacy data from a double-blind control trial (n=76) evaluating patients with essential tremor unresponsive to medication therapy. Of the total patients, 56 patients were randomized to ExAblate Neuro treatment and 20 to a fake (control) treatment; those in the control group were able to cross over to the treatment group three months later. The results showed patients treated with ExAblate Neuro achieved nearly a 50% improvement in their composite tremor/motor function score three months post-treatment vs. baseline. Patients in the control group showed no improvement and some even experienced a slight worsening post-procedure before crossing over to the treatment group.
At 12 months post-procedure, the treatment group sustained a 40% improvement in their scores vs. baseline. Adverse events associated with ExAblate Neuro were consistent with those reported for thalamotomy surgery
“Patients with essential tremor who have not seen improvement with medication now have a new treatment option that could help them to avoid more invasive surgical treatments,” said Carlos Peña, Ph.D., M.S., director of the division of neurological and physical medicine devices in the FDA’s Center for Devices and Radiological Health. “As with other treatments for essential tremor, this new device is not a cure but could help patients enjoy a better quality of life.”
For more information visit FDA.gov.