FDA Expands Indication for Ultrasound Device to Include Treatment of PD Patients

December 27, 2018

The Food and Drug Administration (FDA) has approved an expansion of the indication for Exablate Neuro to include the treatment of patients with tremor-dominant Parkinson disease (PD).

Insightec’s Exablate Neuro is a focused ultrasound device for performing incisionless thalamotomy guided by magnetic resonance imaging. This expansion adds medication-refractory tremor from PD to the current Exablate Neuro indication for incisionless, focused ultrasound thalamotomy for medication-refractory essential tremor.

Jeff Elias, MD, University of Virginia School of Medicine (Charlottesville, VA), said, “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. While focused ultrasound is not curative for Parkinson’s disease, it can provide significant quality of life benefits. Research continues for the other symptoms of Parkinson’s.”1

During focused ultrasound treatment, sound energy passes safely through a patient’s skull with no surgical incisions to heat and precisely ablate the target in the thalamus. The treatment allows the neurosurgeon to create a personalized treatment plan and to evaluate feedback of the patient’s symptom relief or potential side effects in real-time.

According to Insightec, this technology has the ability to help PD patients by reducing their motor symptoms and improving their quality of life.

Amanda Del Signore


1. INSIGHTEC Announces FDA Approval of Exablate Neuro for the Treatment of Tremor-Dominant Parkinson's Disease [news release]. Haifa, Israel: INSIGHTEC; December 18, 2018. Accessed December 19, 2018.