InSightec Receives FDA Go-ahead to Begin Trial for Essential Tremor Therapy

InSightec Ltd. has announced that it received FDA approval to begin Phase III clinical trial for treatment of essential tremor using ExAblate Neuro. This trial is intended to provide safety and effectiveness data about the use of ExAblate Neuro in order to support FDA pre-marketing approval.

ExAblate Neuro uses MR-guided focused ultrasound therapy to provide an incision-less treatment, 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 the most common movement disorder and affects millions of people worldwide. Patients may become severely disabled and have difficulty performing everyday tasks such as drinking, eating, dressing, and writing. More than one-third of patients do not respond to medication and may consider surgery, including implantation of deep brain stimulating electrodes or radiosurgery with ionizing radiation. For more information, click here to read the full release.