Michael Kaplitt, MD, PhD, from Weill Cornell Medicine, discussed the FDA’s new authorization of Insightec’s Exablate Neuro for staged bilateral pallidothalamic tractotomy in advanced Parkinson’s disease (PD). The MRI-guided focused ultrasound (MRgFUS) platform delivers incisionless, hardware-free lesions, expanding beyond prior approvals (eg, essential tremor, tremor-dominant PD, unilateral pallidotomy). The decision was supported by a phase 3, multicenter study (NCT04728295), with full results pending. Kaplitt noted rising patient interest in less invasive options, while emphasizing that MRgFUS creates a permanent ablation and thus permanent effects—underscoring the need for careful patient selection and counseling.
He contrasted MRgFUS with deep brain stimulation (DBS): MRgFUS offers outpatient, incisionless therapy without implanted devices or battery maintenance, whereas DBS provides adjustability, reversibility, and programmability that can be valuable for evolving symptoms. The new indication broadens options for patients with complex motor complications who have not responded to medications, as Insightec plans a limited 2025 rollout and works toward routine reimbursement. Overall, Kaplitt framed the approval as both a validation of clinical utility and a prompt for individualized, risk–benefit discussions when choosing between MRgFUS and DBS.
Reference: Kaplitt M, Ciccone I. Expanding Parkinson Treatment Options With Newly Approved Focused Ultrasound: Michael Kaplitt, MD, PhD. NeurologyLive. Published July 15, 2025. Accessed October 24, 2025. https://www.neurologylive.com/view/expanding-parkinson-treatment-options-newly-approved-focused-ultrasound-michael-kaplitt
