INSIGHTEC, a company out of Israel, has announced receiving FDA approval to offer its Exablate Neuro MRI-guided focused ultrasound system as a treatment option for essential tremor in patients not responding to meds. The technology delivers sound waves powerful and focused enough to non-invasively ablate bits of brain tissue responsible for generating improper neural signals. Treatment is fairly short, and results are often confirmed within seconds, before the patient is even pulled out of the machine. Anesthesia is not necessary during the procedure, and the patient gets to go home right after.
Some details of the study that led to the FDA’s decision, according to INSIGHTEC:
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.
Here’s a year old video from University of Virginia Health System about using focused ultrasound to treat essential tremor:
Flashbacks: Exablate Neuro MRI-Guided Focused Ultrasound: Cleared in EU for Neurological Disorders…; ExAblate MR Guided Focused Ultrasound Approved in U.S. for Pain Treatment in Cancer Patients with Bone Metastases…; MRI Guided Focused Ultrasound for Noninvasive Treatment of Prostate Cancer…