ENROLLMENT IN FIRST MRGFUS ESSENTIAL TREMOR FEASIBILITY TRIAL COMPLETED
INSIGHTEC Ltd, the global leader in MR guided Focused Ultrasound (MRgFUS) therapy, announced today that it has completed enrollment in the world’s first feasibility study evaluating the use of MRgFUS for treatment of Essential Tremor, using Exablate Neuro at University of Virginia, Charlottesville, Virginia. The trial was a result of a partnership between the University of Virginia, INSIGHTEC, and the Focused Ultrasound Foundation, which organized and funded the study.
Fifteen patients underwent a non-invasive Exablate treatment to evaluate safety and initial effectiveness of this investigational device. Most patients, who suffered for at least 10 years, experienced tremor improvement and no severe adverse events. They are being followed up for three months.
Exablate Neuro, pioneered by INSIGHTEC, combines high intensity focused ultrasound for deep accurate lesioning of the brain, with continuous realtime MR guidance for visualizing brain anatomy, planning and monitoring treatment and outcome. The lesioning is performed through an intact skull with no incisions or ionizing radiation.
Additional research using MRgFUS for chronic neuropathic pain, targeted drug delivery, and sonothrombolysis for acute ischemic stroke is described in the January issue of Neurosurgical Focus devoted to MR guided focused ultrasound applications for central nervous system disorders.
“The safety profile of ExAblate Neuro and initial clinical efficacy are extremely encouraging” said Dr. Jeff Elias, principal investigator, Director of Stereotactic and Functional Neurosurgery and Associate Professor of Neurological Surgery and Neurology, UVA. Dr. Elias presented interim results at the European MRgFUS symposium in Rome (http://bit.ly/sVntp3) and at the Congress of Neurological Surgery in Wash DC.
Essential tremor, a very common movement disorder, affects millions of people worldwide. They have difficulty performing everyday tasks like drinking, eating, dressing, and writing. One third do not respond to medication, and may consider surgery. These have well recognized risks: high doses of ionizing radiation, complications and side effects from invasive surgery.
MRgFUS was investigated as an alternative for these medically refractory patients.
“Exablate Neuro, the only MRgFUS brain system in clinical use, has demonstrated the ability to ablate targets deep in the brain with high precision. Encouraging initial results provide hope that this treatment could become a significant addition for treating neurological disorders”, said Eyal Zadicario, VP of R&D and Director of INSIGHTEC’s Neuro program. “INSIGHTEC is expanding its Neuro research, to include brain tumors, stroke and targeted drug delivery.”