The US Food and Drug Administration (FDA) has approved Insightec’s Exablate Neuro platform for staged bilateral pallidothalamic tractotomy in patients with advanced Parkinson’s disease (PD). The decision allows clinicians to treat both sides of the brain in separate procedures using focused ultrasound, a non-invasive approach that does not require incisions or implanted devices.
The expanded indication is intended for patients experiencing severe motor symptoms such as rigidity, bradykinesia, and dyskinesia that have not responded adequately to medication.
“This new indication represents a significant step forward in how integrated movement disorder teams will approach the treatment of Parkinson’s disease,” said Dr. Michael Kaplitt, a neurosurgeon at Weill Cornell Medicine-New York Presbyterian Hospital, and lead investigator in the clinical trial that supported FDA approval.
The trial, conducted at nine sites across the United States, Europe, and Asia, assessed the safety and effectiveness of the staged bilateral procedure. Detailed results from the study are expected later this year.
Expanding Options for Parkinson’s Patients
Parkinson’s Foundation estimates that the disease affects nearly 1.1 million people in the US, a number expected to rise to 1.2 million by 2030. While medications such as levodopa remain the standard of care, many patients eventually experience diminishing benefits or adverse effects, leading to a need for alternative treatments.
Focused ultrasound uses sound waves to target and ablate specific areas of brain tissue implicated in movement disorders. Guided by magnetic resonance imaging (MRI), the technique allows clinicians to perform the procedure without surgical incisions or anesthesia, and with a lower risk of complications compared to traditional brain surgery.
Dr. Arif Dalvi, Director of the Comprehensive Movement Disorders Center at Palm Beach Health Network and one of the investigators in the trial, said the ability to treat both sides of the brain in a staged fashion could help patients with disabling symptoms regain some function.
History of Approvals and Future Access
Exablate Neuro was previously approved for unilateral use in treating essential tremor in 2016 and tremor-dominant Parkinson’s disease in 2018. In 2021, the FDA cleared the platform for unilateral pallidotomy to address Parkinson’s-related dyskinesia and motor symptoms. The bilateral approval now broadens its potential application for advanced PD.
According to Insightec, over 25,000 patients worldwide have been treated with its focused ultrasound technology for various movement disorders. The company plans a limited launch of the bilateral procedure at select centers in 2025 while working to secure routine insurance reimbursement.
In recent years, Insightec has introduced updated versions of its technology, including Exablate Prime, which integrates with certain Philips MRI systems and features software enhancements aimed at improving workflow and targeting accuracy.
Ongoing Developments in Focused Ultrasound
The FDA’s clearance of staged bilateral procedures highlights a broader trend of expanding non-invasive neurosurgical techniques. Unlike deep brain stimulation, which requires implanting electrodes, focused ultrasound offers an outpatient alternative that some patients may prefer for its lower procedural burden.
However, experts caution that longer-term data will be important to fully understand the benefits and potential risks of bilateral treatments. While unilateral procedures have been in use for several years, the effects of treating both sides of the brain remain under study.
The company has indicated that full trial data will be published later in 2025, providing more clarity on outcomes and safety profiles.
Sidebar: Focused Ultrasound vs. Deep Brain Stimulation (DBS)
| Feature | Focused Ultrasound | Deep Brain Stimulation (DBS) |
| Procedure Type | Incisionless, outpatient | Requires brain surgery and implants |
| Mechanism | Uses sound waves to ablate target tissue | Sends electrical impulses via implanted electrodes |
| Recovery Time | Minimal, often same-day discharge | Longer, involves surgical recovery |
| Reversibility | Irreversible (ablation) | Reversible (stimulation can be adjusted or stopped) |
| Anesthesia Required | No | Yes |
