INSIGHTEC has announced that the FDA has approved its Exablate Neuro (Model 4000) system for use with 1.5T MRI in the non-invasive treatment of essential tremor (ET) in patients who have not responded to medication. Exablate Neuro uses focused ultrasound waves to target and ablate the Vim nucleus of the thalamus with no surgical incisions or implants. The treatment is done under MRI guidance for real-time treatment monitoring.
In July 2016, INSIGHTEC received FDA approval for the Exablate Neurofor use with 3.0T MRI systems. This approval for a new MR head coil significantly opens new potential markets for INSIGHTEC’S Exablate Neuro as 1.5T systems are the most common MRI systems in use today.
Essential tremor is the most common movement disorder, affecting more than 42 million people worldwide. For patients suffering from essential tremor, performing everyday tasks presents a challenge and impacts their quality of life.
“Being able to bring MR-guided focused ultrasound to hospitals that have 1.5T MRIs will enable more essential tremor patients to have access to this non-invasive treatment option using INSIGHTEC’s ground-breaking technology.” stated Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board.