- The final long-term data from the pivotal trial of focused ultrasound ablation for essential tremor were published in the Journal of Neurosurgery.
- The data confirm that focused ultrasound is effective for reducing tremors.
- The 40 patients who completed the follow-up at five years maintained a 73% tremor reduction.
The final long-term data report from the pivotal trial of focused ultrasound ablation for essential tremor (ET) was recently published in the Journal of Neurosurgery.
From the 76 participants in the original clinical trial, 45 and 40 completed the four- and five-year follow-up visits, respectively. These participants experienced 73% tremor reduction over baseline at five years post-treatment. Other notable scores remained stable over time, and no new adverse events were reported.
The study was led by University of Virginia neurosurgeon Jeff Elias, MD, and conducted at eight centers in the US, Canada, South Korea, and Japan. It was funded by a partnership between the Focused Ultrasound Foundation, device manufacturer Insightec, and the Israel-US Binational Industrial R&D (BIRD) Foundation.
“These data confirm that focused ultrasound can be a durable treatment for essential tremor,” said Dr. Elias. “And the procedure is relatively new, so we expect continued improvements in the technology.”
When this pivotal study was originally completed, the 12-month results were published in the New England Journal of Medicine in August 2016. The success of the trial led the US Food and Drug Administration to approve Insightec’s Exablate Neuro device to treat ET. Since FDA approval, more than 7,800 commercial patients have been treated.
The treatment is now reimbursed throughout the US by Medicare and several private insurance carriers. It is also reimbursed in Canada, Germany, Italy, Switzerland, the UK, Israel, and Japan.