FDA Approves Ultrasound Device to Treat Essential Tremor

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FDA Approves Ultrasound Device to Treat Essential Tremor
FDA Approves Ultrasound Device to Treat Essential Tremor

MONDAY, July 11, 2016 (HealthDay News) -- The ExAblate Neuro device has been approved by the U.S. Food and Drug Administration to deliver focused ultrasound to destroy tissue in a tiny area of the brain that is thought to be involved in essential tremor.

The device, approved for patients who haven't responded to medication or surgery, uses magnetic resonance imaging (MRI) to help doctors focus ultrasound on specific areas of the brain, the FDA explained Monday in a news release. Patients are awake and responsive during the entire procedure, the agency added.

The device was evaluated in a clinical study involving 76 participants. Those who used the ExAblate device showed nearly a 50 percent improvement in essential tremor, compared to those who used a sham device. Side effects of the ExAblate device included finger numbness, headache, unsteadiness, ataxia, and gait disturbance. Additional potential side effects included skin burns, scar formation, and blood clots, the FDA said.

The device shouldn't be used by patients who cannot have an MRI, including those who have had implantation of a metallic medical device such as a pacemaker, the agency said. Pregnant women and patients with advanced kidney disease, unstable heart conditions, or hypertension also shouldn't have the procedure.

The ExAblate Neuro device is produced by InSightec, based in Dallas.

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