The European Union has granted CE mark approval to InSightec's transcranial focused ultrasound system for the treatment of essential tremor, tremor dominant Parkinson's disease and neuropathic pain.
The non-invasive ExAblate Neuro utilizes MR guided Focused ultrasound (MrgFUS), which combines therapeutic acoustic ultrasound waves with continuous MRI guidance, for treating tissue deep in the brain through an intact skull.
The MRI facilitates physicians to visualize, plan, guide, monitor and control the treatment, while the ultrasound acoustic energy destroys the targeted tissue in the brain, claims the company.
InSightec president Kobi Vortman said results from the clinical studies, conducted on ExAblate Neuro, showed that patients 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," Vortman added.
In addition to CE mark, ExAblate has gained FDA approval for the treatment of painful bone metastases and uterine fibroids.