AANS Neurosurgeon | Volume 29, Number 2, 2020


Essential Tremor Marks One Year Since FDA Approval

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The field of focused ultrasound achieved a critical milestone in July 2016 with the approval of the first ever brain indication for the technology in the US. The Food and Drug Administration (FDA) approved Insightec’s Exablate Neuro focused ultrasound system for the non-invasive treatment of essential tremor (ET), the most common movement disorder.

The approval was based on data from a multicenter pivotal study led by W. Jeffrey Elias, MD, at the University of Virginia, in which 76 patients with ET experienced a nearly 50 percent improvement in their motor function three months after focused ultrasound treatment and retained 40 percent of the improvement after one year. 

“This action by the FDA has affirmed focused ultrasound’s ability to safely and accurately treat the brain through the intact skull in an awake patient, and we are so pleased that focused ultrasound for ET is now becoming a part of American neurosurgery practice,” said Focused Ultrasound Foundation Chairman, Neal F. Kassell, MD. “The Foundation has long concentrated on treating the brain, as it is a high bar. If you can achieve success in the brain, it is not difficult to imagine treating many more targets in less challenging organs.”

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