EC grants CE mark to InSightec’s ExAblate Neuro ultrasound system
Published on December 4, 2012 at 7:09 AM
InSightec Ltd. announced that its transcranial focused ultrasound system, ExAblate Neuro, has been awarded the European CE mark for the treatment of neurological disorders in the brain including essential tremor, Parkinson's disease and neuropathic pain.
Millions of people suffer from neurological disorders which cause significant disability and negatively affect their quality of life and that of their caretakers. Treatment options for patients who do not respond to drug treatments include deep brain stimulation, radiofrequency ablation and radiosurgery which are invasive or involve ionizing radiation and are associated with recognized risks: high doses of ionizing radiation or high risk of complications and side effects including infection, bleeding and collateral brain tissue damage.
"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 Dr. Kobi Vortman, President of InSightec. "Results from the clinical studies showed that patients, many of whom who 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 ionizing radiation, which treats tissue deep in the brain through an intact skull. MR guided Focused ultrasound (MRgFUS) combines therapeutic acoustic ultrasound waves with continuous MRI guidance," added Eyal Zadicario, Vice President of R&D and Director of InSightec's Neuro program. "The MRI enables physicians to visualize, plan, guide, monitor and control the treatment while the ultrasound acoustic energy destroys the targeted tissue in the brain."
InSightec recently received its second ExAblate FDA approval for the treatment of painful bone metastases in patients who are unable or unwilling to undergo radiation. This is in addition to FDA approval for the treatment of uterine fibroids received in 2004. The CE marking enables ExAblate Neuro to be sold in Europe.