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FDA Approves Ultrasound Device for Essential Tremor
FDA news release; 2016 Jul 11
The FDA has approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication. ExAblate Neuro (InSightec, Dallas, TX; www.insightec.com/clinical/neurosurgery/) uses magnetic resonance (MR) images to deliver focused ultrasound that destroys brain tissue in a tiny area thought to be responsible for causing tremors.
Indications: To determine if ExAblate Neuro treatment is appropriate, patients should first have MR and computerized tomography (CT) scans.
Dosage/administration: Those undergoing treatment lie in an MRI scanner that takes images to help a doctor identify the targeted area in the brain’s thalamus. Treatment with the 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.
Adverse reactions: Adverse events for the ExAblate Neuro are consistent with those reported for thalamotomy surgery, including numbness/tingling of the fingers, headache, imbalance/unsteadiness, and loss of body control movements (ataxia) or gait disturbance.
FDA approves first MRI-guided focused ultrasound device to treat essential tremor. [news release]. July 11, 2016: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510595.htm. Accessed July 12, 2016.
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