InSightec Ltd announced has received FDA approval to begin its Phase III clinical trial for treatment of essential tremor using ExAblate Neuro. ExAblate Neuro uses MR guided focused ultrasound therapy to provide treatment without incision, through the intact skull, with no ionizing radiation. ExAblate MR guided focused ultrasound (MRgFUS) uses high intensity ultrasound waves to destroy target tissue in the brain while the patient lies in an MRI, which provides continuous visualization, plan, guidance, monitoring, and control of the treatment.
Essential tremor is a movement disorder that affects millions of people worldwide. More than one third of patients do not respond to medication, and some consider surgery including implantation of deep brain stimulating electrodes or radiosurgery with ionizing radiation. The Phase III study will be a multi-center, double blinded randomized control trial, with one-year follow-up. Patients who enroll in the trial will be randomized to either ExAblate treatment or no treatment. The first patients are expected in mid 2013.
