1) FDA labeling: The Exablate Neuro is intended for use in the unilateral thalamotomy treatment of idiopathic essential tremor patients with medication-refractory tremor. Patients must be at least age 22.
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Risks associated with any thalamotomy include transient and/or permanent sensory paresthesias, numbness, imbalance, and/or gait disturbance. These events are generally transient and mild or moderate in severity. Risks and adverse events also associated with the Exablate Neuro treatment include brief sonication-related pain, brief sonication-related dizziness and nausea or potential for deep vein thrombosis associated with lengthy time on the treatment bed.