FDA approves first new device for the treatment of essential tremor

The US Food and Drug Administration recently approved the first focused ultrasound device for the treatment of patients with essential tremor that are unresponsive to medication.

“Patients with idiopathic tremors that have not improved their medications now have a new treatment option that can help them avoid more invasive surgery,” said Carlos Pea of ​​the FDA Center for Medical Devices and Radiation Hygiene, “with other idiopathic Like tremor therapy, this new device does not cure the disease but can help patients enjoy a higher quality of life."

Idiopathic tremor, also known as benign essential tremor, is the most common form of tremor. According to the National Institute of Neurological Disorders and Stroke, millions of people in the United States are affected by the disease, usually over 40 years of age. We may use beta blockers or anticonvulsants to treat essential tremors. In cases where the drug does not control the symptoms of the disease, surgery (thalamic incision) may be performed or a deep brain stimulation device may be used to destroy a small portion of the brain (thalamic) to control some unconscious movements.

To determine if ExAblate Neuro treatment is appropriate, patients must first undergo MR and computed tomography (CT) scans. Patients undergoing MRI-guided device therapy rely on MRI scans to obtain images to help the physician determine the target area of ​​the thalamus that needs treatment. The patient is always awake and responsive throughout the course of treatment.

Data supporting the safety and efficacy of the device system included a double-blind controlled trial involving 76 patients with essential tremor who did not respond to medication. Fifty-six patients were randomized to receive ExAblate Neuro and 20 received sham treatment. Patients in the control group can cross the treatment group after three months.

FDA approves first new device for the treatment of essential tremor

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