One year ago this month, the field of focused ultrasound achieved a critical milestone with the approval of the first ever brain indication for the technology in the US. The Food and Drug Administration approved Insightec’s Exablate Neuro focused ultrasound system for the non-invasive treatment of essential tremor, the most common movement disorder.
Essential tremor is the most common movement disorder, affecting an estimated 3% of the population, or approximately 10 million people in the US. While it is commonly viewed as a relatively benign disease, essential tremor's associated disabling aspects – such as significant tremor of the hands – can impair patients’ ability to eat, shave, write, perform household activities, and function at work.
In the US, focused ultrasound for ET is currently available at Brigham & Women's Hospital, Ohio State University, Penn Medicine, Sperling Medical Group, Stanford University School of Medicine, Swedish Neuroscience Institute, University of Maryland School of Medicine, University of Virginia Health System, and Weill Cornell Medical Center. Focused ultrasound is also approved to treat ET in Europe, Korea, Canada, Israel, Japan, and Russia. The treatment is not yet widely reimbursed by medical payers at this time in Europe or the US.
The idea of using focused ultrasound (FUS) to treat tremors was conceptualized in March 2009 at the Foundation's first brain workshop. Given the challenges of accessing the brain and the high cost, complications, and limitations of other approaches, the Foundation believes that FUS has the potential to revolutionize the treatment of many brain disorders – and ultimately open up opportunities to rapidly advance applications throughout the body.
In November 2016, the Centers for Medicare and Medicaid Services (CMS) set the institutional payment for focused ultrasound treatment for essential tremor at approximately $10,000. The next step toward widespread reimbursement is for local insurance intermediaries to follow suit in establishing coverage.
The Foundation recently spoke with Dr. Vibhor Krishna, MD, ScM, about his fascinating work with focused ultrasound and the brain, research highlights, and his future goals for the field. Dr. Krishna is an Assistant Professor, Center for Neuromodulation, Department of Neurosurgery and Department of Neuroscience, at The Ohio State University in Columbus, Ohio with a focus on treatments and techniques of deep brain stimulation, spinal cord stimulation, peripheral nerve stimulation, and high intensity focused ultrasound.
Peter Muller – a Naval Academy graduate, Vietnam naval aviator, and a Wharton MBA graduate – has enjoyed many successes in his life. Now, he includes being a focused ultrasound patient among that list.
Insightec’s Exablate Neuro is approved in the US, Canada, Europe, Israel, Korea, Japan, and Russia for the treatment of essential tremor. It is also CE marked to treat Parkinsonian Tremor and Neuropathic pain. Researchers around the world are working to assess the system in the treatment of several other related movement disorders.
The Foundation recently spoke with Maurice R. Ferre, MD, Insightec’s CEO and Chairman of the Board of Directors, to learn more about the company’s role in bringing focused ultrasound to patients around the world for a wide variety of applications including treating essential tremor. Read on to learn more about the company, their vision and accomplishments, and their plans for the future in the fast-growing focused ultrasound market.