Insightec gains US FDA nod for five-year endpoint in MR-guided focused ultrasound study

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Insightec has announced US Food and Drug Administration (FDA) approval of the five-year study endpoint for what it claims is the largest prospective, long-term follow-up study of unilateral magnetic resonance-guided focused ultrasound (MRgFUS) surgery, or ‘thalamotomy’, for essential tremor to date.

The data from this study show sustained and significant tremor improvement at five years with an overall improvement in quality-of-life measures, and without any progressive or delayed complications, a company press release states.

The study also confirms the long-term efficacy of the procedure for sufferers of essential tremor, and follows the recent US FDA approval of use of the technology to treat ‘second-side’ tremor in appropriate patients.

The randomised, controlled, multicentre study—published in the Journal of Neurosurgery last year—describes the long-term safety and efficacy of unilateral MRgFUS thalamotomy for the treatment of medication-refractory essential tremor using Insightec’s Exablate system.

“The FDA approval validates the years of work that we have invested into using focused ultrasound as a front-line therapy for essential tremor,” said Maurice R Ferré, 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.”


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