FDA Approves Focused Ultrasound for Tremor-Dominant Parkinson’s Disease
FDA Approves Focused Ultrasound Therapy for Tremor-Dominant Parkinson’s Disease
Insightec's Exablate Neuro device
On December 18, 2018, device manufacturer Insightec announced that their Exablate Neuro device has earned approval from the US Food and Drug Administration to treat patients with Parkinson’s disease whose main symptom is tremor.
Focused ultrasound has been shown to help reduce Parkinson's disease symptoms, which include tremor, rigidity, slowness of movement, and postural instability. It is estimated that between 10 and 20 percent of Parkinson’s patients have what is considered tremor-dominant Parkinson’s.
"This is another validation of a great technology," said Jeff Elias, MD, of the University of Virginia (UVA) School of Medicine. "Patients are attracted to the less invasive aspects of focused ultrasound. Now Parkinson's patients, for whom tremor is their primary disability, have more treatment options than conventional cranial surgery.”
This approval was based on a clinical trial of 27 patients at UVA and Swedish Neuroscience Institute in Seattle, led by Elias. The results of that study, which was funded in part by the Foundation, were published in JAMA Neurologyin December 2017. The previous year, the FDA approved focused ultrasound to treat essential tremor, a benign condition with similar symptoms.
“This ruling by the FDA is an important step in treating many patients with a variety of symptoms from Parkinson’s disease,” said Foundation Chairman Neal F. Kassell, MD. “We congratulate the team at Insightec on this achievement, and the Foundation will continue to support research to make focused ultrasound widely available to patients with a variety of disorders.”