The ExAblate Neuro device has been approved by the U.S. Food and Drug Administration to deliver focused ultrasound to destroy small bits of brain tissue that are thought to be involved in a neurological condition known as essential tremor.
The device, approved for people who haven’t responded to medication or surgery, uses MRI scans 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.
Essential tremor is the most common form of tremor, the medical term for involuntary shaking or trembling. The condition affects several million Americans, most often aged 40 or older, the FDA said.
The device was evaluated in a clinical study involving 76 people. Those who used the ExAblate device showed nearly a 50 percent improvement in essential tremor, compared to those who used a fake device.
Side effects of the ExAblate device included finger numbness, headache, unsteadiness, loss of complete body control and walking disturbance. Additional potential side effects included skin burns, scar formation and blood clots, the FDA said.
The device shouldn’t be used by people who cannot have an MRI, including people who have had implantation of a metallic medical device such as a pacemaker, the agency said. Pregnant women and people with advanced kidney disease, heart disease or high blood pressure also shouldn’t have the procedure.
The ExAblate device is produced by InSightec, based in Dallas.