Patients with medication-resistant essential tremors will now have access to an FDA-approved focused ultrasound device called ExAblate Neuro. The device from InSightec, which received FDA approval on July 11, uses MR images captured during the procedure to deliver focused ultrasound with the goal of destroying brain tissue in the small area of the brain that’s causing tremors.
Several million Americans—generally those over the age of 40—are impacted by essential tremors, according to the National Institute of Neurological Disorders and Stroke. The most common treatments for such tremors include beta blockers or anticonvulsant drugs; surgery and deep brain stimulation have also provided relief for patients.
To determine if the focused ultrasound treatment is appropriate, patients must first undergo an MRI and a CT scan. During the treatment, the patient lies in an MRI scanner that captures images to guide their physician to the targeted area in the brain’s thalamus. Provided to patients by increases in energy to deliver a reduction in tremors, the focused ultrasound treatment is administered while patients are awake and responsive.
In a double-blind control trial conducted with 76 patients with medication-resistant essential tremor, those treated with the ExAblate Neuro demonstrated nearly a 50% improvement in their tremors and motor function three months after treatment, as compared with their baseline score. A full year after treatment, patients retained a 40% improvement in such scores, as compared with their baseline score.
“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,” says Carlos Peña, PhD, 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 about this system, visit InSightec.