FDA approves new MRI-guided essential tremor treatment

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A new treatment is now an FDA-approved option for patients with essential tremor. On July 11, the agency approved using an MRI-guided focused ultrasound to treat essential tremor cases that haven’t responded to medication.

According to a statement by the FDA, the product, manufactured by the Texas-based Exablate Neuro, uses an ultrasound to kill specific bits of brain tissue that are causing the tremor. The ultrasound is guided by live data obtained during an MRI scan.

Patients who were treated with this device showed a 50 percent improvement after three months compared to no improvement or worsening symptoms in the control group. For 40 percent of those treated, those improvements continued even a year after treatment.

The FDA’s Director of the Division of Neurological and Physical Medicine Devices, Carlos Peña, PhD, MS said in a statement, “As with other treatments for essential tremor, this new device is not a cure but could help patients enjoy a better quality of life.”

This new treatment could help patients see improvements while steering clear of surgeries, even after certain medications have failed.  

The FDA advised that the treatment was only approved for patients who have not respond well to anticonvulsant or beta-blocking drugs, can tolerate MRIs and have already had MRIs and CTs of the brain.

According to the National Institute of Neurological Disorders and Stroke, essential tremor is the most common form of tremor, affecting millions of Americans mostly older than 40.