Insightec Gets FDA Blessing for Study of Exablate Neuro to Treat Parkinson’s Involuntary Movements
The U.S. Food and Drug Administration (FDA) has granted approval to Insightec to start a pivotal study of its Exablate Neuro technology. The ultrasound therapy aims to treat advanced Parkinson’s disease patients with involuntary muscle movements and motor fluctuations who don’t respond to medication.
The principal investigator is Dr. Howard Eisenberg, a neurosurgery professor at the University of Maryland School of Medicine. Recognized as one of the nation’s top neurosurgeons and pre-eminent experts on traumatic brain injury and the blood brain barrier, Eisenberg also chairs the department of neurosurgery at the University of Maryland Medical Center in Baltimore.
Parkinson’s is marked by uncontrolled, involuntary movement of the arms or legs. Known as dyskinesia, it compromises patients’ quality of life and daily activities. Exablate Neuro is an innovative medical device that uses focused ultrasound — along with magnetic resonance imaging (MRI) — to precisely target and destroy by heat a specified area deep within the brain, through an intact skull.
The MRI part of this technology lets doctors guide the treatment planning and deliver thermal feedback in real-time monitoring.
In July 2016, this medical device became the first focused ultrasound apparatus approved by the FDA to treat medication-resistant essential tremor patients with non-invasive thalamus destruction. The Vim nucleus of the thalamus has been identified as the target responsible for causing Parkinson’s tremors. To destroy it, the Exablate Neuro focuses 1,024 ultrasound waves — generating enough heat to ablate the targeted tissue. This causes an immediate, significant reduction in hand tremors.
With Parkinson’s affecting millions of people worldwide, this technology has the ability to help Parkinson’s patients by reducing their motor symptoms and improving their quality of life, says the Israeli-based company. More than 30 Exablate Neuro systems are currently in use in Canada, Germany, Israel, Italy, Japan, South Korea, Spain, Switzerland and the United States.
“Insight remains committed to advancing research to expand indications for our incisionless focused ultrasound technology to improve patient lives,” Dr. Maurice R. Ferré, Insightec’s CEO and chairman of the board, said in a press release.