Insightec gets FDA approval for Exablate Neuro system to treat essential tremor

13 July 2016 (Last Updated November 22nd, 2018 11:20)

Israel-based medical device company Insightec has secured the US Food and Drug Administration (FDA) approval of its Exablate Neuro system to treat essential tremor (ET) in patients unresponsive to medication.

Israel-based medical device company Insightec has secured the US Food and Drug Administration (FDA) approval of its Exablate Neuro system to treat essential tremor (ET) in patients unresponsive to medication.

Exablate Neuro offers a non-invasive treatment and uses focused ultrasound waves for a precise targeting and a subsequent ablation of tissue deep within the brain.

The treatment is done based on magnetic resonance imaging (MRI) guidance for real time treatment monitoring.

"The patients we have treated show immediate tremor control, allowing them to regain ability to perform daily tasks such as eating and writing."

It facilitates an immediate tremor improvement after the outpatient procedure with minimal risk of infection, bleeding or other surgical complications.

The procedure involves a single session with no anesthesia allowing a quick recovery of the patients.

The FDA approval is based on the clinical data of a randomised, double-blind, multi-centre clinical trial which was designed to determine the safety and efficacy of non-invasive thalamotomy with MRgFUS.

The trial enrolled 76 patients of which 56 received Exablate treatment while the rest received the sham treament which was the same procedure without any ultrasound energy.

University of Virginia stereotactic and functional neurosurgery director and principal investigator of study Dr Jeffrey Elias said: "Results of this study show that Exablate Neuro is safe and effective for treating essential tremor.

“Finding the most effective way to manage tremor symptoms is crucial for patients.

“The patients we have treated show immediate tremor control, allowing them to regain ability to perform daily tasks such as eating and writing."

Exablate Neuro has also been assigned with the CE mark to treat essential tremor, tremor dominant Parkinson's disease and neuropathic pain.