FDA Approves Insightec's Exablate Neuro for Advanced Parkinson's Disease Treatment
Key Insights
The FDA has approved Insightec's Exablate Neuro (search) focused ultrasound system for treating advanced Parkinson's disease (search) patients with mobility, rigidity, or dyskinesia (search) symptoms through incisionless pallidotomy.
The treatment uses focused ultrasound waves to precisely target and ablate the globus pallidus (search) without requiring brain implants or surgical incisions, reducing infection risk compared to invasive surgery.
This approval expands the device's indications beyond essential tremor (search) and tremor-dominant Parkinson's disease (search), with 37 medical centers in the US currently using the technology.
The U.S. Food and Drug Administration has approved Insightec's Exablate Neuro (search) focused ultrasound system for treating advanced Parkinson's disease (search) patients suffering from mobility, rigidity, or dyskinesia (search) symptoms. The approval, announced on November 3, 2021, represents a significant expansion of treatment options for the estimated one million Americans living with this neurodegenerative disorder.
Incisionless Pallidotomy Technology
The Exablate Neuro (search) uses focused ultrasound waves to precisely target and ablate the globus pallidus (search) (GPi) during a pallidotomy procedure. Unlike traditional surgical approaches, the treatment requires no incisions, does not require brain implants, and carries less risk of infection than invasive surgery.
"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, MD, PhD, professor of neurology, pharmacology and neurobiology at the University of Maryland School of Medicine.
During the focused ultrasound treatment, sound energy passes safely through a patient's skull to heat and precisely ablate the target tissue. The procedure allows neurosurgeons to create personalized treatment plans and evaluate patient symptom relief or potential side effects in real-time.
Clinical Significance for Parkinson's Disease
Parkinson's disease (search) is characterized by tremor, rigidity, slow movement (bradykinesia), and postural instability as its cardinal features. When medication induces side effects or is not well tolerated, surgical treatments such as focused ultrasound may be considered.
"This approval is significant in that it adds Focused Ultrasound as an incisionless surgical option to treat motor symptoms of Parkinson's disease (search)," said Howard M. Eisenberg, MD, R.K. Thompson Professor, Department of Neurosurgery at the University of Maryland and Principal Investigator.
The approval was based on data from studies led at the University of Virginia School of Medicine and conducted at Swedish Neuroscience Institute (search) in Seattle. Patients must be at least 30 years of age to receive the treatment.
Expanding Treatment Portfolio
This latest approval builds on the Exablate Neuro (search)'s previous FDA approvals for medication-refractory Essential Tremor (search) in 2016 and Tremor-dominant Parkinson's Disease (search) in 2018. Currently, 37 medical centers in the United States use the Insightec Exablate Neuro device to treat patients with medication-refractory Essential Tremor and Tremor-dominant Parkinson's Disease.
"This expanded approval of clinical indications to treat Parkinson's Disease (search) signifies the growing understanding and acceptance of Focused Ultrasound as an effective treatment modality," commented Maurice R. Ferré MD, 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 approval represents another validation of focused ultrasound technology, with patients attracted to its less invasive aspects compared to conventional cranial surgery. While focused ultrasound is not curative for Parkinson's disease (search), it can provide significant quality of life benefits for patients whose primary disability is tremor.