November 22, 2021
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FDA approves device for treatment of advanced PD

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The FDA has granted approval to Insightec for Exablate Neuro, a new device for treating patients with advanced Parkinson's disease who suffer from mobility, rigidity or dyskinesia symptoms, according to a press release.

The device uses focused ultrasound waves to target the globus pallidus and remove it during a surgical procedure. The treatment does not involve making an incision, does not require an implant and decreases the risk for infection compared with surgery.

"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 at the University of Maryland School of Medicine, said in a release.

The Exablate Neuro device received previous approvals from the FDA for treatment of medication-refractory essential tremor in 2016 and for tremor-dominant PD 2 years later. At present, 37 medical centers in the U.S. use the device to treat patients living with medication-refractory essential tremor and tremor-dominant PD.

"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 R. Ferré MD, Insightec CEO and chairman of the board of directors, added. "More importantly, it drives our continued efforts to help transform the lives of people living with debilitating neurological and other conditions."