The Food and Drug Administration approved the Exablate Neuro system as the first focused ultrasound device intended to treat essential tremor in patients who do not respond to conventional medication.
Exablate Neuro, developed by Dallas-based InSightec, relies on information from magnetic resonance images to deliver focused ultrasound energy that destroys tissue in a small area of the brain that controls involuntary movement.
Patients are awake and responsive during the procedure as physicians gradually administer increasing amounts of ultrasound energy until they achieve a reduction of the involuntary shaking.
"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, 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."
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