FDA approves MRI-guided focused ultrasound device to treat essential tremor

The U.S. Food and Drug Administration has approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication. ExAblate Neuro, manufactured by InSightec in Dallas, Texas, uses magnetic resonance (MR) images taken during the procedure to deliver focused ultrasound to destroy brain tissue in a tiny area thought to be responsible for causing tremors.

“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.”

To determine if the ExAblate Neuro treatment is appropriate, patients should first have MR and computerized tomography (CT) scans. Those undergoing treatment with the MRI-guided device lie in an MRI scanner that takes images to help a doctor identify the targeted area in the brain’s thalamus for treatment. Treatment with transcranial focused ultrasound energy is administered with incremental increases in energy until patients achieve a reduction of tremor. Patients are awake and responsive during the entire treatment.