FDA approval of Exablate Neuro for the treatment of tremor-dominant Parkinson’s disease

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InSightec has announced that The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) has approved an expansion of the indication of Exablate Neuro to include the treatment of patients with tremor-dominant Parkinson’s disease.

The Exablate Neuro is a focused ultrasound device for performing incisionless thalamotomy guided by MR imaging. This expansion adds medication-refractory tremor from Parkinson’s disease to the current Exablate Neuro indication for incisionless, focused ultrasound thalamotomy for medication-refractory essential tremor.

“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,” said Jeff Elias, of the University of Virginia School of Medicine.

“Focused ultrasound has the potential to improve the quality of life of patients living with medication-refractory tremor, whether from essential tremor or Parkinson’s disease,” said Maurice R Ferré, InSightec CEO and chairman of the board. “This is an important milestone in expanding focused ultrasound treatment for a growing number of neurological indications.”

During the 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 personalised treatment plan and to evaluate feedback of the patient’s symptom relief or potential side effects in real-time. Patients must be at least 30 years of age.

This approval was based on data from a study led at the University of Virginia School of Medicine and was also conducted at Swedish Neuroscience Institute in Seattle. The device is indicated for unilateral thalamotomy with medication-refractory tremor patients.

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