Israel-based medical device company Insightec has reported positive pivotal study results of its Exablate Neuro system for the non-invasive treatment of essential tremor (ET).
The system 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.
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 randomised, double-blind, multi-centre clinical study involved 76 patients, of which 56 were randomly subjected to the Exablate treatment and 20 received the sham procedure which is the same procedure without transmission of ultrasound energy.
Patients in this placebo treatment later underwent an Exablate Neuro treatment.
The study was designed to test the safety and efficacy of Exablate Neuro while treating essential tremor in subjects who were unresponsive to medication.
Results of the study suggested the safety and efficacy of the Exablate Neuro with clinical improvement noted in the composite tremor score as compared to the score of the scam cohort after three months.
Tremor Research Group president Dr William Ondo said: "The robust study findings showed that focused ultrasound safely improved hand tremor in patients with refractory tremor by precisely targeting and ablating deep brain tissue without surgical incisions, thus minimising risk of infection, bleeding or other complications sometimes seen in surgical operations."
The Exablate Neuro has recently received the US Food and Drug Administration (FDA) approval.
Image: Insightec’s Exablate Neuro System. Photo: courtesy of INSIGHTEC Ltd.