Ultrasound Device Approved

FDA www.fda.gov has approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medications. ExAblate Neuro manufactured by InSightec www.insightec.com in Dallas uses an MRI taken during a 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 improved with medication now have a new treatment option that could help them to avoid more invasive surgical treatment,” said Carlos Pena, PhD, Director, Division of Neurological and Physical Medicine Devices in the FDA Center for Devices and Radiological Health www.fda.gov/MedicalDevices/default.htm.

Essential tremor also called benign essential tremor is the most common form of tremor according to the National Institute of Neurological Disorders and Stroke www.ninds.nih.gov. Several million Americans usually those over 40 are affected.

Essential tremor may be treated with beta blockers or anticonvulsant drugs. If medications fail to control symptoms, the condition may also be treated with surgery or with a deep brain stimulation device to destroy the tiny part of the brain that controls some involuntary movements.

To determine if the ExAblate Neuro treatment is appropriate, patients should first have an MRI and computerized tomography 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 the tremor. Patients are awake and responsive during the entire treatment.

It has been shown in trials that patients treated with the ExAblate Neuro showed nearly a fifty percent improvement in their tremors and motor function three months after treatment compared to their baseline score.