Insightec has announced that the US Food and Drug Administration (FDA) has approved the Exablate Neuro device for treating advanced Parkinson’s disease patients suffering from mobility, rigidity or dyskinesia symptoms.
The Exablate Neuro uses focused ultrasound waves to precisely target and ablate the globus pallidus (GPi) during a pallidotomy. The treatment is incisionless, does not require brain implants, and has a lower risk of infection than invasive surgery, according to an Insightec press release.
“Movement disorder neurologists now can offer their Parkinson’s patients a less invasive surgical option as part of their treatment plan,” said Paul S Fishman, professor of neurology, pharmacology and neurobiology at the University of Maryland School of Medicine (Baltimore, USA).
“This approval is significant in that it adds focused ultrasound as an incisionless surgical option to treat motor symptoms of Parkinson’s disease,” added Howard M Eisenberg, R.K. Thompson Professor in the Department of Neurosurgery at the University of Maryland (Baltimore, USA).
Parkinson’s disease, a neurodegenerative disorder, affects an estimated one million patients in the USA. Tremor, rigidity, slow movement (bradykinesia) and postural instability are the cardinal features of the disorder. When medication induces side-effects or is not well-tolerated, surgical treatments, such as focused ultrasound, may be considered, the release adds.
“This expanded approval of clinical indications to treat Parkinson’s disease signifies the growing understanding and acceptance of focused ultrasound as an effective treatment modality,” said Maurice R Ferré, Insightec CEO and chairman of the Board of Directors. “More importantly, it drives our continued efforts to help transform the lives of people living with debilitating neurological and other conditions.”
The Exablate Neuro received FDA approval for the treatment of medication-refractory essential tremor in 2016 and for tremor-dominant Parkinson’s disease in 2018, and there are currently 37 medical centres in the USA using the device to treat patients with these conditions.