Focused Ultrasound Approved for Advanced Parkinson’s

The FDA expanded the approval of Exablate Neuro focused ultrasound to treat advanced Parkinson’s disease patients with mobility, rigidity, or dyskinesia symptoms, device maker Insightec announced Wednesday.

With this new indication, Exablate Neuro is approved for unilateral pallidotomy in medication-refractory Parkinson’s patients with moderate to severe motor complications.

The device uses MRI-guided focused ultrasound waves to target and ablate the globus pallidus, requiring no incisions or brain implants. “Movement disorder neurologists now can offer their Parkinson’s patients a less invasive surgical option as part of their treatment plan,” said Paul Fishman, MD, PhD, of the University of Maryland, in a statement.

Exablate Neuro previously was approved to treat medication-refractory essential tremor and tremor-dominant Parkinson’s disease.

Early studies suggested that focused ultrasound subthalamotomy and pallidotomy performed on one side may reduce motor manifestations of Parkinson’s disease. A sham-controlled trial of patients with markedly asymmetric Parkinson’s disease found that focused ultrasound subthalamotomy performed in one hemisphere resulted in improved motor scores at 4 months, but was associated with adverse events including dyskinesias and other neurologic complications.

Deep-brain stimulation (DBS) has been used to treat Parkinson’s disease and predominantly has targeted the subthalamic nucleus or the internal segment of the globus pallidus, but some patients are wary of DBS surgery and hardware, noted Joel Perlmutter, MD, and Mwiza Ushe, MD, both of Washington University in St. Louis, in a New England Journal of Medicine editorial.

Focused ultrasound “has the advantage of producing lesions without the need for craniotomy,” Perlmutter and Ushe observed.

The expanded indication for Exablate Neuro was based on a pivotal randomized trial of unilateral focused ultrasound pallidotomy in refractory, advanced idiopathic Parkinson’s disease.

“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 Ferré, MD, Insightec’s chairman and CEO. “More importantly, it drives our continued efforts to help transform the lives of people living with debilitating neurological and other conditions.”

Last Updated November 05, 2021