Pivotal study of Exablate Neuro system for essential tremor published in New England Journal of Medicine - Insightec

INSIGHTEC announced that the New England Journal of Medicine (NEJM) has published the results of a pivotal study of their Exablate Neuro system for the non-invasive treatment of essential tremor (ET). The study met its primary endpoint with patients treated with Exablate Neuro demonstrating a clinically significant 47% improvement in a composite tremor score at three months as compared to no change in the sham cohort. The NEJM article presents findings from an FDA study designed to evaluate the safety and efficacy of Exablate Neuro for the treatment of essential tremor in subjects for whom medications were not effective. Results of this randomized, double-blind, multi-center clinical study were submitted as the key data resulting in FDA approval of INSIGHTEC's Exablate Neuro as the first focused ultrasound device to treat essential tremor.

Seventy-six patients were enrolled in the study and randomly assigned to receive the Exablate treatment (56 patients) or the sham procedure (20 patients), the exact same procedure but without transmission of ultrasound energy. Patients in the placebo treatment arm were later allowed to undergo an Exablate Neuro treatment. Patients in the treatment group showed a 63.4% reduction in tremor amplitude alone (CRST A) which was maintained at one year follow up. Additionally, the total disability score (CRST part C) improved by 68% and patient assessment of their quality of life (QUEST) improved by 51% overall at 12 months for treated patients. Most adverse events were transient, minimal or unrelated to the Exablate Neuro procedure.

See: "A Randomized Trial of Focused Ultrasound Thalamotomy for Essential Tremor" W. Jeffrey Elias N Engl J Med 2016; 375:730-739 August 25, 2016 DOI: 10.1056/NEJMoa1600159