FDA Approves Focused Ultrasound to Treat Essential Tremor
The US Food and Drug Administration (FDA) has approved Insightec’s Exablate Neuro system to treat essential tremor, marking the first for a brain indication in the US.
The approval was based on data from a multicenter pivotal study led by W. Jeffrey Elias, MD at the University of Virginia. Seventy-six patients with essential tremor achieved nearly a 50 percent improvement in their tremors and motor function three months after treatment. They retained a 40 percent improvement after one year. More details are available in the FDA’s press release.
“We have reached a critical milestone in focused ultrasound's evolution,” says Foundation Chairman, Neal F. Kassell, MD. “This approval affirms the technology’s ability to safely and accurately treat the brain through the intact skull in an awake patient. The Foundation has long focused 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 targets in less challenging organs."
This achievement exemplifies the Foundation’s mission to accelerate the development and adoption of focused ultrasound by fostering collaboration and supporting research. The idea of utilizing focused ultrasound to treat tremors was originally conceptualized at the first brain workshop convened by the Foundation in March 2009. We then helped organize and fund a pilot study in collaboration with Insightec and the University of Virginia that served as the predicate for this larger pivotal study.
The recent study was a collaboration between Insightec, the Foundation and eight academic medical centers. It was funded by a partnership between the Focused Ultrasound Foundation, Insightec and the BIRD (Israel-US Binational Industrial R&D) Foundation.
The Foundation is engaged in additional brain research including Parkinson's disease, epilepsy, brain tumors, OCD and depression, dystonia, and Alzheimer's disease. We are exploring focused ultrasound to not only destroy tissue, but to stimulate the immune system and open the blood-brain barrier to deliver drugs. In addition, we support a variety of technical projects to make brain treatment safer, faster, and more effective.
We want to congratulate Insightec, and we sincerely thank the generous donors who have helped make our efforts and this milestone a reality.
READ INSIGHTEC'S PRESS RELEASE >