Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

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.

Citation:

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.