InSightec announced that its investigational ExAblate Neuro system has been used in clinical studies to treat 30 patients suffering from chronic neurological disorders. The clinical trials are being conducted by functional neurosurgeons, neurologists and neuroradiologists in Switzerland, and the USA to evaluate the safety and initial efficacy of the system for treating essential tremor, neuropathic pain and Parkinson’s disease.
ExAblate Neuro is the first clinical system to use magnetic resonance guided focused ultrasound (MRgFUS) through an intact skull, combining focused ultrasound and real time magnetic resonance guidance and control, to treat tissue deep in the brain without incisions or cutting or ionising radiation.
“The concept of using focused ultrasound for non-invasive treatment of brain disorders has been recognised for many years, however, vast technical barriers had to be overcome to enable this modality to become a reality. We have invested tremendous technological and clinical efforts to be able to reach this point and are very encouraged by the clinical results so far”, said Eyal Zadicario, vice-president of R&D and director of the Neuro programme at InSightec.
“ExAblate Neuro has demonstrated the ability to ablate targets deep in the brain with high precision. The initial results have been encouraging. This gives us hope that this treatment alternative could in the future become a significant addition to the physicians’ armamentarium in treating functional brain diseases.” he continued.
The intra-operative image guidance built into ExAblate Neuro is designed to allow precision control and accurate delivery to the planned target with continuous real time feedback throughout the treatment.
Ongoing clinical research will evaluate the ability of this technology to reduce the risk of complications and side-effects. It may provide a treatment option for those individuals where surgery is currently not an option, or refuse an intervention of the brain.
InSightec is planning to expand its Neuro research platform with additional clinical trials for brain tumors, stroke and targeted drug delivery to the brain.
The ExAblate system received the European CE mark for uterine fibroids in 2002, for pain palliation of bone metastases in June 2007 and for adenomyosis in June 2010. It was approved by the FDA in 2004 for symptomatic uterine fibroids. Over 8,000 patients have been treated worldwide with ExAblate systems.