The US Food and Drug Administration (FDA) has expanded approval of Insightec’s Exablate Neuro focused ultrasound device to include the treatment of patients with advanced Parkinson’s disease (PD) suffering with mobility, rigidity, or dyskinesia symptoms.

InsightecLogoAfflicting approximately one million people in the US, PD has no cure, and the major options for treatment of motor symptoms include drug therapy and invasive surgery (e.g., deep brain stimulation or radiofrequency lesioning). For certain patients, focused ultrasound offers a noninvasive alternative to surgery with a lower risk of complications and lower cost. 

Focused ultrasound uses ultrasound energy guided by real-time imaging to treat tissue deep in the body without incisions or radiation. Insightec’s Exablate Neuro is a helmet-like device that emits ultrasound waves and focuses them to target and destroy the part of the brain associated with these symptoms of PD.

The FDA’s decision was based on data from the pivotal clinical trial that evaluated patients with advanced and medication-refractory PD. The trial took place at five sites in the US as well as locations in Canada, Japan, and Korea. The final data in that clinical trial – led by Howard Eisenberg, MD, R.K. Thompson Professor, Department of Neurosurgery at the University of Maryland – has not yet been published. However, data from the preliminary clinical trial – which was funded by the Foundation, The Michael J. Fox Foundation for Parkinson's Research, and Insightec – were published in the Journal of Neurosurgery.

“This approval is significant in that it adds focused ultrasound as an incisionless surgical option to treat motor symptoms of Parkinson’s disease,” said Dr. Eisenberg

“The Foundation has long considered the brain to be a vanguard target for focused ultrasound, and this ruling by the FDA is a huge win for both providers and patients,” added Foundation Chairman, Neal F. Kassell, MD.

In July 2016, the FDA approved focused ultrasound for the first brain indication – essential tremor. In December 2018, it was approved to treat tremor-dominant PD, which affects approximately 10-20% of the Parkinson’s population. It is also approved to treat uterine fibroids, pain from cancer that has spread to the bone, osteoid osteomas, and prostate diseases.

It is important to note that focused ultrasound does not currently address the underlying cause of PD but rather offers relief from the debilitating symptoms.

There are currently 37 medical centers in the US using Insightec’s Exablate Neuro device to treat tremor-dominant PD.

For Patients
We encourage you to learn more about the Exablate Neuro device and its use for PD on the Insightec website. 

Patients with Parkinson's disease who are interested in receiving focused ultrasound should contact a treatment site to inquire if they are a candidate and if/how to gain access to the treatment. The procedure is not yet covered universally by Medicare or private insurers, so patients may need to pay out-of-pocket or coordinate with their doctor to seek coverage from their insurance provider.

Read Insightec’s Release >

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