FDA Expands Exablate Neuro’s Use as Motor Symptom Treatment

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by Patricia Inácio, PhD |

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The U.S. Food and Drug Administration has approved Insightec’s incision-free brain “surgery” technology — Exablate Neuro — for the treatment of motor symptoms in Parkinson’s disease patients.

According to the company, the device is indicated to use in patients with moderate-to-severe motor complications, such as tremors, stiffness and uncontrolled, involuntary movement of the arms or legs (dyskinesia), who fail to respond to standard Parkinson’s therapies.

Exablate Neuro was approved in the U.S. in 2016 for the treatment of essential tremor in patients who do not respond to standard therapies and since 2018 for tremor-dominant Parkinson’s. China recently approved Exablate Neuro for the same indications.

“This expanded approval of clinical indications to treat Parkinson’s Disease signifies the growing understanding and acceptance of Focused Ultrasound as an effective treatment modality,”  Maurice Ferré, MD, chairman and CEO at Insightec, said in a press release.

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“More importantly, it drives our continued efforts to help transform the lives of people living with debilitating neurological and other conditions,” Ferré said.

In people with Parkinson’s disease, a part of the brain — the globus pallidus — is overactive, causing muscular rigidity and uncontrollable and involuntary muscle movements.

Exablate Neuro uses magnetic resonance-guided focused ultrasound to precisely target, heat and ablate, or gradually remove, a tiny part of the globus pallidus. This reduces its activity and lessens motor symptoms, such as tremor and stiffness.

Most importantly, Exablate Neuro requires no surgical incisions, anesthesia, or brain implants, as in the case of deep brain stimulation (DBS), so it is expected to carry a lower risk for infections.

DBS is a surgical procedure that eases motor symptoms. It is an invasive procedure, however, that involves implanting a device to stimulate targeted regions of the brain with electrical impulses generated by a battery-operated neurostimulator to regain motor control.

“Movement disorder neurologists now can offer their Parkinson’s patients a less invasive surgical option as part of their treatment plan,” said Paul S. Fishman, MD, PhD, professor of neurology, pharmacology and neurobiology at the University of Maryland School of Medicine.

“This approval is significant in that it adds Focused Ultrasound as an incisionless surgical option to treat motor symptoms of Parkinson’s disease,” said Howard M. Eisenberg, MD, professor in the department of Neurosurgery at the University of Maryland.

Exablate Neuro already is being used in 37 medical centers across the U.S. for the treatment of patients with essential tremor and tremor-dominant Parkinson’s disease who failed to respond to medications.

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