News & Press Release

Sort By

INSIGHTEC, the leader in MR-guided Focused Ultrasound (MRgFUS) therapy, announced today that the FDA has approved its Exablate Neuro system for the non-invasive treatment of essential tremor (ET) in patients who have not responded to medication.

Exablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions or implants. The treatment is done under Magnetic Resonance Imaging (MRI) guidance for real time treatment monitoring. The patient experiences immediate tremor improvement following the outpatient procedure. The treatment carries minimal risk of infection, bleeding or other surgical complications. The treatment requires a single session with no anesthesia, allowing patients to quickly return to normal activity.

Essential tremor is the most common movement disorder, affecting more than 5 million people in the United States, and millions more worldwide. Hand tremor is the most common symptom, but tremors can also affect the head, arms, voice, legs, and torso. For these patients, performing everyday tasks presents a challenge and impacts their quality of life.

This approval by the FDA was based on clinical data from a randomized, double-blind, multi-center clinical study designed to evaluate the safety and efficacy of non-invasive thalamotomy with MRgFUS. A total of 76 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 any ultrasound energy. Patients in the placebo treatment arm were later allowed to undergo an Exablate Neuro treatment. Patients treated with the Exablate Neuro showed nearly a 50% improvement in their tremors and motor function three months after treatment compared to their baseline score. Patients in the control group had no improvement, and some experienced a slight worsening after the sham procedure before they crossed over into the treatment group. A year following the procedure, the patients who underwent the Exablate Neuro procedure retained a 40% improvement in these scores compared to baseline.

“Results of this study show that Exablate Neuro is safe and effective for treating essential tremor. Finding the most effective way to manage tremor symptoms is crucial for patients. The patients we have treated show immediate tremor control, allowing them to regain ability to perform daily tasks such as eating and writing,” commented Dr. W. Jeffrey Elias, Director of Stereotactic and Functional Neurosurgery at the University of Virginia and Principal Investigator in the study.

Earlier this year, Exablate was also approved by Health Canada for essential tremor.

“This newly FDA approved device provides a new treatment option without some of the complications associated with surgery to offer patients with essential tremor. Furthermore, it holds promise for a range of neurosurgical procedures,” noted Andres Lozano, MD, Dan Family Professor and Chairman of Neurosurgery at Toronto Western Hospital, University of Toronto and Investigator in the study.

“I am confident that we have arrived at a tipping point for non-invasive medical treatment. Focused ultrasound has the unique ability to precisely ablate target tissue deep within the body. With Exablate Neuro, INSIGHTEC expands its Exablate product line with a system that signifies a new era for functional neurosurgery,” stated Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board.

NON-INVASIVE AND SAFE PROCEDURE ALLOWS PATIENTS TO QUICKLY RETURN TO NORMAL ACTIVITY

INSIGHTEC, the leader in MR-guided Focused Ultrasound (MRgFUS) therapy, today 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.

“MRI imaging and thermometry provide a high level of control during focused ultrasound thalamotomy. Importantly, before treatment, adjustments can be made based on intraoperative imaging and clinical feedback from the patient, contributing to a safe procedure,” said Dr. W. Jeffrey Elias, Director of Stereotactic and Functional Neurosurgery at the University of Virginia and primary author of the NEJM paper.

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.

“The robust study findings showed that focused ultrasound safely improved hand tremor in patients with refractory tremor by precisely targeting and ablating deep brain tissue without surgical incisions, thus minimizing risk of infection, bleeding or other complications sometimes seen in surgical operations.” said Dr. William G. Ondo, Tremor Research Group President.

The primary endpoint combined the Clinical Rating Scale for Tremor (CRST) Part-A and Part-B, an 8-element measure of tremor and hand function. For the Exablate Neuro treatment group, a mean score of 18.1±4.8 at baseline was reduced to 9.6±5.1 at 3 months (47% change), while the sham group showed no change, demonstrating a highly statistically significant (p<0.001) difference between groups.

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.

“We are pleased with the results of this pivotal study that addresses a major issue for the five million Americans and millions more worldwide that suffer from this debilitating disease,” said Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board. “With this positive data and the subsequent FDA approval of the Exablate Neuro system, patients can be treated and return to performing everyday tasks with greater ease and enjoy a better quality of life.”

The sites participating in the clinical study included: University of Virginia, Stanford University Medical Center, University of Maryland, Brigham and Women’s Hospital, Swedish Medical Center, Yonsei University Medical Center (South Korea), Sunnybrook Health Sciences Centre (Canada) and Tokyo Women’s Medical University (Japan).

Funding for the study was provided by the Focused Ultrasound Foundation and BIRD (US-Israel Binational Industry R&D) and INSIGHTEC.
Exablate Neuro has now received FDA, Health Canada and Korean approval for essential tremor and CE mark in Europe for essential tremor, tremor dominant Parkinson’s disease and neuropathic pain.

For the complete NEJM study click here