Insightec, a global healthcare company dedicated to using focused ultrasound (FUS) technology to transform patient care, today announced FDA approval of the five-year study endpoint for the largest prospective long-term, follow-up study of unilateral MR-guided focused ultrasound (MRgFUS) surgery (thalamotomy) for essential tremor (ET) to date. The data shows sustained and significant tremor improvement at five years with an overall improvement in quality-of-life measures and without any progressive or delayed complications. The study also confirms the long-term efficacy of the procedure for sufferers of ET, and follows the recent FDA approval of use of the technology to treat the second side tremor of appropriate patients. Insightec’s Focused Ultrasound technology has been used to perform over 11,000 procedures worldwide.
“The FDA approval validates the years of work that we have invested into using Focused Ultrasound as a front-line therapy for ET,” said Maurice R. Ferré, MD, CEO and the Chairman of the Board of Directors at Insightec. “It also substantiates that using MR-guided focused ultrasound to treat essential tremor is safe and effective, as well as long-lasting. We look forward to making further progress in finding more uses for focused ultrasound and building on the success of the treatment of essential tremor.”
The randomized, controlled, multi-center study describes the long-term safety and efficacy of unilateral MRgFUS thalamotomy for the treatment of medication-refractory essential tremor using the Exablate System.
The data showed the durability of tremor reduction in patients’ (n=40) treated hand, which remained significantly improved at five years. This 73.1% improvement in tremor severity (CRST Part A) is considered clinically meaningful and is consistent with previously published data from this cohort.
Importantly, quality of life (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 5 years.
“Being part of the clinical study 7 years ago was life changing,” says Alexandra Lebenthal, a clinical trial Focused Ultrasound patient from 2016. “I have been able to focus on life and my career every day without needing to work around and hide my tremor. I’m looking forward to having my other hand treated soon.”