ExAblate Neuro transcranial focused ultrasound system gets the CE mark for the treatment of neurological disorders


On 4 December, InSightec announced that its transcranial focused ultrasound system, ExAblate Neuro, has been awarded the CE mark for the treatment of neurological disorders including: essential tremor, Parkinson’s disease and neuropathic pain. 

Treatment options for patients who do not respond to drug treatments include deep brain stimulation, radiofrequency ablation and radiosurgery which are invasive or involve ionising radiation and are associated with recognised risks such as high doses of ionising radiation or high risk of complications and side effects including infection, bleeding and collateral brain tissue damage.

According to the company, ExAblate Neuro integrates high intensity focused ultrasound surgery with continuous magnetic resonance imaging (MRI) to provide a non invasive, acoustic surgery platform for treating neurological disorders without ionising radiation through an intact skull.

“ExAblate offers great potential for treating brain disorders. Because of its targeting accuracy, real time treatment monitoring and ability to provide non-invasive brain treatment, there is hope that many people who suffer from neurological diseases can benefit from this treatment,” said Kobi Vortman, president of InSightec. “Results from the clinical studies showed that patients, many of whom suffered for years from neurological disorders, experienced immediate symptom improvement with a high safety profile. These patients are now better able to conduct activities of daily living and are also less dependent on external caregiver support.”

“ExAblate Neuro offers a non-invasive treatment with no ionising radiation, which treats tissue deep in the brain through an intact skull. MR guided focused ultrasound combines therapeutic acoustic ultrasound waves with continuous MRI guidance,” said Eyal Zadicario, vice president of R&D and director of InSightec’s Neuro programme. “The MRI enables physicians to visualise, plan, guide, monitor and control the treatment while the ultrasound acoustic energy destroys the targeted tissue in the brain.”

On 20 August 2012, the company announced
the FDA approval to begin a phase I clinical trial evaluating the use of its ExAblate Neuro system for the treatment of  patients with tremor dominant Parkinson’s Disease.