The approval expands the devices existing indications for medication-refractory essential tremor and tremor-dominant Parkinson disease.
The Exablate Neuro device has received FDA approval to treat patients with advanced Parkinson disease experiencing mobility, rigidity, or dyskinesia symptoms, Insightec announced earlier this month.1
The device uses focused ultrasound waves to target the globus pallidus (GPi) during a pallidotomy, without requiring an incision. The device requires no brain implants and poses a lower risk of infection when compared to invasive surgery. It has already been approved for treatment of medication-refractory essential tremor (ET), granted in 2016, and was later approved for the treatment of tremor-dominant PD in 2018. A total of 37 centers in the US are currently utilizing the device to treat this patient population.
“This expanded approval of clinical indications to treat Parkinson disease signifies the growing understanding and acceptance of focused ultrasound as an effective treatment modality,” Maurice R. Ferré, MD, CEO and chairman of the board of directors, Insightec, said in a statement.1 “More importantly, it drives our continued efforts to help transform the lives of people living with debilitating neurological and other conditions.”
Using a helmet-shaped ultrasound inducer, the Exablate Neuro device also has adjustable advanced focusing algorithms to ensure beams converge at the desired target on the patient’s skull. The process is performed on an outpatient basis in an MRI suite, with treatment guided by the MR imaging. "Movement disorder neurologists now can offer their Parkinson's patients a less invasive surgical option as part of their treatment plan," Paul S. Fishman, MD, PhD, professor of neurology, pharmacology and neurobiology, University of Maryland School of Medicine, said in a statement.1
The 2018 FDA approval for treatment of patients with tremor-dominant PD was based on data from a randomized clinical trial (NCT01772693) examining the safety and efficacy of focused ultrasound (FUS) thalamotomy in managing medically refractory, tremor-dominant PD, also measuring the magnitude of placebo response.
Twenty-seven patients with tremor-dominant PD were included in the pilot trial, randomized 2:1 to undergo focused ultrasound thalamotomy (n = 20) or a sham procedure (n = 7). Results showed that a statistically significant difference in on-medication Clinical Rating Scale for Tremor A+B treated hand tremor subscores, with those in the FUS thalamotomy group improving by a median of 7 points or 62% (interquartile range [IQR], 22%–79%) from a baseline of 17 points (IQR, 10.5–27.5), and those in the sham group improving by 2 points or 22% (IQR, –11% to 29%) from a baseline of 23 points (IQR, 14.0–27.0). Similarly, on-medication median Unified Parkinson’s Disease Rating Scale motor scores improved by 8 points (IQR, 0.5–11.0) from a baseline of 23 points (IQR, 15.5–34.0) following FUS thalamotomy and 1 point (IQR, −5.0 to 9.0) from a baseline of 25 points (IQR, 15.0–33) after sham procedures.2
The initial FDA approval, granted in 2016, made Exablate Neuro the first FUS device to received approval for treatment of medication refractory ET with noninvasive MR-guided FUS thalamotomy. Treatment with transcranial FUS is performed while patients are awake and responsive, delivering incremental increases in energy until a reduction of tremor is achieved.3