Expanding Parkinson Treatment Options With Newly Approved Focused Ultrasound: Michael Kaplitt, MD, PhD

WATCH TIME: 5 minutes

"I think the idea of focused ultrasound, in general, has been gaining more and more traction because patients certainly like the idea of a less invasive approach to treatment. Having said that, focused ultrasound also is a permanent ablation of a small spot in the brain, and that can have permanent effects."

Insightec’s Exablate Neuro platform utilizes MRI-guided focused ultrasound to accurately target areas in the pallidothalamic tract through an incisionless procedure that does not require any implanted hardware. Recently, the FDA approved the use of Exablate Neuro for staged bilateral pallidothalamic tractotomy in patients with advanced Parkinson disease (PD), covering both the initial and subsequent procedures. The approval was supported by positive findings from a phase 3 study (NCT04728295) performed at 9 sites across the United States, Europe and Asia, with full results expected to be published later this year.¹

Prior to the recent indication, the platform was approved for unilateral treatment of medication-refractory essential tremor (ET), tremor-dominant PD, unilateral pallidotomy for PD-related dyskinesia and motor symptoms and staged unilateral treatment for ET on the contralateral (second) side. This new expanded indication for patients offers a therapeutic option for those with severe motor symptoms of PD who have not yet had relief from previous treatments. Insightec is planning a limited launch of the bilateral procedure at selected centers in 2025, alongside ongoing efforts to create routine reimbursement pathways and improve patient access.

Following the news of the approval, movement disorder expert Michael Kaplitt, MD, PhD, professor of neurological surgery at Weill Cornell Medicine, sat down with NeurologyLive^® to reflect on the challenges and rewards of the assessing focused ultrasound treatment for PD, emphasizing the role of patients, investigators, and regulatory bodies. In the interview, he underscored how the recent FDA approval of the therapy not only validated its clinical potential, but also broadened treatment options beyond tremor management, particularly for those with complex motor symptoms. Furthermore, he compared the benefits and risks of focused ultrasound versus deep brain stimulation for the treatment of patients with PD, reinforcing the importance of individualized care decisions.

REFERENCES
1. Insightec Announces FDA Approval of Staged Bilateral Focused Ultrasound Treatment for Parkinson’s Disease. News Release. Insightec. Published July 8, 2025. Accessed July 9, 2025. https://insightec.com/news/insightec-announces-fda-approval-of-staged-bilateral-focused-ultrasound-treatment-for-parkinsons-disease/