Insightec has announced the publication of what it claims is the largest prospective, long-term follow-up study to date of unilateral magnetic resonance imaging-guided focused ultrasound (MRgFUS) thalamotomy for essential tremor, demonstrating sustained and significant tremor improvements that were maintained out to five years.
This multicentre randomised controlled study, which was conducted at eight centres in the USA, Canada, South Korea and Japan, and recently published in the Journal of Neurosurgery, describes the long-term safety and efficacy of unilateral MRgFUS thalamotomy for medication-refractory essential tremor using the company’s Exablate system.
The data showed the durability of tremor reduction in patients’ (n=40) treated hand, which remained significantly improved at five years. The 73.1% improvement in tremor severity (Clinical Rating Scale for Tremor [CRST] Part A) observed at five years in the study is considered clinically meaningful and is consistent with previously published data from this cohort, an Insightec press release notes.
Quality of life (Quality of Life in Essential Tremor Questionnaire [QUEST]) and functional disability (CRST Part C) also remained sustained from baseline. In addition, no new adverse events related to the procedure were reported from the 12-month timepoint to the last follow-up at five years.
According to Insightec, the publication therefore shows that unilateral Exablate MRgFUS thalamotomy demonstrates sustained and significant tremor improvements at five years with an overall improvement in quality-of-life measures, and without any progressive or delayed complications.
“We are happy to see the results from this study,” said Insightec CEO Maurice Ferré. “The sustained tremor improvement over five years is a testament to the tireless work of our doctors and partner treatment centres. These data show that using MRI-guided focused ultrasound to treat essential tremor is safe and effective. We will continue future progress in finding other treatment options for patients for whom focused ultrasound can be a life-altering option.”
