The prestigious New England Journal of Medicine published the pivotal study that led to the approval of Insightec’s Exablate Neuro focused ultrasound system to treat essential tremor (ET).

 
 

Sharon Samuels shares her struggle with essential tremor and
gets her quality of life back after focused ultrasound treatment.

The ET patients treated in this study achieved significantly reduced unilateral hand tremor that proved durable at 12 months. The procedure also reduced disability and improved quality of life one year after treatment. The study was conducted at eight centers and led by University of Virginia neurosurgeon Jeff Elias, MD.

“This study represents a major advance for neurosurgery, treatment of brain disease and specifically the treatment of essential tremor,” Dr. Elias said. “For the first time in a randomized controlled trial, we have shown that ultrasound can be precisely delivered through the intact human skull to treat a difficult neurological disease.”

“This publication further affirms to the medical community that focused ultrasound is a safe and effective alternative to treat the brain without incisions or radiation,” says Foundation Chairman Neal Kassell, MD. “Now that Insightec’s system is approved by the FDA, the important next step is to secure the appropriate levels of reimbursement so that leading medical centers will invest in this technology and make it widely available to patients seeking non-invasive options for their tremors.”

Given the challenges of accessing the brain and the high cost, complications, and limitations of some current approaches, we believe that focused ultrasound has the potential to revolutionize the treatment of many brain disorders and ultimately to open up opportunities to rapidly advance applications throughout the body.

The idea of using focused ultrasound to treat tremors was conceptualized at the Foundation's first brain workshop in March 2009. The Foundation then helped organize and fund a pilot study with Insightec and the University of Virginia that served as the predicate for this larger pivotal study.

NEJM ET video320 captionThe pivotal study was funded by a partnership between the Focused Ultrasound Foundation, Insightec and the BIRD (Israel-US Binational Industrial R&D) Foundation.

Read the University of Virginia's press release >

The pivotal trial took place at the following sites:

  • Brigham & Women's Hospital
  • Stanford University Medical Center
  • Sunnybrook Health Sciences Centre
  • Swedish Medical Center
  • University of Maryland Medical System
  • University of Virginia 
  • Tokyo Women's Medical University
  • Yonsei University Medical Center

 

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