HAIFA, Israel and MIAMI, Florida – May 2, 2018 – Insightec®, a global medical technology innovator of incisionless surgery, today announced the treatment of its first patient in the FDA pivotal study for addressing advanced Parkinson’s disease in patients who have not responded to medication.
Insightec’s Exablate Neuro™ medical device uses focused ultrasound together with magnetic resonance (MR) imaging to treat a target deep within the brain. For Parkinson’s disease patients, treatment is intended to improve motor function and reduce dyskinesia. Dyskinesia is one of the debilitating symptoms that presents as uncontrolled, involuntary movement of the arms and legs, which often occurs as a side effect of medication. The device is FDA-approved to treat patients suffering from essential tremor who have not responded to medication. The Parkinson’s disease study represents the next stage in addressing other movement disorders.
“Building on the success of the incisionless focused ultrasound treatment for essential tremor, we are excited to extend its application to the debilitating effects of Parkinson’s disease,” said Howard Eisenberg, MD, the Raymond K. Thompson, MD Chair in Neurosurgery, and Professor, Department of Neurosurgery, University of Maryland School of Medicine.
The study is listed on clinicaltrials.gov and patients are being enrolled at ten international medical centers with leading Parkinson’s investigators. This pivotal trial follows the pilot trial partially funded by the Focused Ultrasound Foundation and the Michael J. Fox Foundation for Parkinson’s Research.
“Insightec is committed to supporting focused ultrasound research, which is much less invasive than conventional surgery, and has the potential of improving the lives of people living with Parkinson’s disease,” commented Maurice R. Ferré MD, Insightec’s CEO and Chairman of the Board of Directors.
The Neuravive™ treatment for medication-refractory essential tremor is currently being performed on a routine basis at leading medical institutions worldwide.
Insightec is a global medical technology innovator transforming patient lives through incisionless brain surgery with MR-guided focused ultrasound. The company’s award-winning Exablate Neuro™ is used by neurosurgeons to perform the Neuravive™ treatment for immediate tremor relief in patients. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. Insightec is headquartered in Haifa, Israel, and Miami, with offices in Dallas, Tokyo and Shanghai.
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