FDA expands indication for Insightec’s Exablate Neuro in Parkinson’s

Insightec said this week that the FDA approved an expansion for the Exablate Neuro device to include the treatment of patients with tremor-dominant Parkinson’s disease.

The company’s device uses focused ultrasound to perform an incision-less thalamotomy, guided by MR imaging. The Exablate Neuro was previously only approved for medication-refractory essential tremor.

“This is another validation of a great technology,” Dr. Jeff Elias of the University of Virginia School of Medicine said in prepared remarks. “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.”

“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,” Insightec CEO & chairman Dr. Maurice Ferré added. “This is an important milestone in expanding focused ultrasound treatment for a growing number of neurological indications.”

In October this year, Insightec won Medicare benefit coverage from CGS Medicare and Palmetto GBA for procedures using its Neuravive MR-guided focused ultrasound system for the treatment of essential tremor.