ExAblate Neuro system MRI-guided ultrasound filed with FDA for essential tremor- Insightec

Insightec has submitted a pre-market approval application (PMA) to the FDA for its Exablate Neuro MRI-guided focused ultrasound surgery (MRgFUS) treatment of essential tremor. Exablate Neuro noninvasive ablation was investigated as a treatment alternative for patients with essential tremor. The PMA submission was based on a two arm randomised controlled trial comparing patients undergoing Exablate MRgFUS treatment with patients undergoing a placebo treatment. Patients in the placebo treatment arm were later allowed to undergo an Exablate Neuro treatment. The FDA granted the Expedited Access Pathway designation.

ExAblate Neuro was awarded the European CE mark for the treatment of neurological disorders in the brain including essential tremor, Parkinson's disease and neuropathic pain in December 2013.

Comment: Essential tremor is the most common movement disorder, affecting more than five million people in the United States, and millions more worldwide. It is a progressive and debilitating neurological condition that causes a rhythmic trembling of the hands, head, voice, legs or trunk.