The FDA Has Approved a Focused Ultrasound Device for Essential Tremor

Exablate Neuro (InSightec, Miami, FL), a noninvasive MR-guided focused ultrasound (MRgFUS) device, has been approved by the Food and Drug Administration (FDA) for the treatment of people with essential tremor (ET) who have not responded to medication. The device was previously approved in 2021 for the treatment of people with drug-refractory Parkinson disease (PD) with mobility, rigidity, or dyskinesia symptoms. Exablate Neuro uses sound waves to ablate targeted brain tissue implants or incisions. The procedure requires no anesthesia and is performed on an outpatient basis, which according to a statement from InSightec, reduces surgical risk and allows treated individuals to resume daily activities almost immediately, according to a press release from InSightec.

The FDA’s decision follows results from a randomized, double-blind, multicenter clinical study (NCT01827904) that included 76 participants aged ≥22 years with a diagnosis of ET. Participants were randomized to receive MRgFUS treatment with the Exablate Neuro device (n=56) or sham treatment (n=20). The primary end point was percent improvement in the Clinical Rating Scale for Tremors (CRST) score from baseline to month 3 of treatment. Researchers calculates CRST scores using 3-components of CRST Part-A (ie, rest, posture, action/intention) and all 5 components of CRST Part-B.   

• After 3 months, participants treated with Exablate Neuro showed a 46.9% improvement from baseline in CRST score (P<.001; 95% CI, 40.3% to 53.5%).
• 1 year after the procedure, participants who received Exablate Neuro treatment maintained a 40% improvement from baseline in CRST score.
• 184 adverse events (AEs) were reported in the Exablate Neuro group (137 mild AEs and 46 moderate AEs).

“Results of this study show that Exablate Neuro is safe and effective for treating essential tremor,” said W. Jeffrey Elias, MD, Director of Stereotactic and Functional Neurosurgery at the University of Virginia and Principal Investigator of the study. “Finding the most effective way to manage tremor symptoms is crucial for patients. The patients we have treated show immediate tremor control, allowing them to regain ability to perform daily tasks such as eating and writing.”