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. The study, a collaboration between Insightec, the Foundation, and eight academic medical centers. was published in the New England Journal of Medicine (NEJM) in August 2016. It was funded by a partnership between the Focused Ultrasound Foundation, Insightec, and the BIRD (Israel-US Binational Industrial R&D) Foundation.
“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.”
ET is a benign neurological condition affecting nearly 10 million people in the US alone. It causes trembling of the hands, head, voice, legs, or trunk and can significantly impact a patient’s quality of life.
“We have arrived at a tipping point for non-invasive neurosurgery,” said Maurice R. Ferré, MD, Insightec Chief Executive Officer and Chairman of the Board. “Focused ultrasound has the unique ability to precisely ablate target tissue deep within the body. With Exablate Neuro, we have expanded our Exablate product line with a system that signifies a new era for functional neurosurgery.”
ET is currently approved in the US, Canada, Europe, Russia, Japan, Korea, and Israel. Centers worldwide are reporting a backlog of several hundred ET patients desiring FUS.
In November 2016, the Division of Outpatient Care within the Centers for Medicare and Medicaid Services (CMS) assigned a hospital payment amount for focused ultrasound treatment for ET. This represents the first critical piece for moving the technology from research to commercial adoption by hospitals. The next step toward widespread reimbursement (in other words, achieving insurance coverage for FUS patients) is for local insurance intermediaries to follow suit in establishing coverage, leading to patient access.
Click here to learn more about other approved indications for focused ultrasound.