FDA Approves Expanded Indication for DBS System to Treat Parkinson Disease

January 26, 2020

The Infinity DBS system is the only directional DBS system approved to target all major areas associated with movement disorders, including Parkinson disease and essential tremor.

Jerrold Vitek, MD, PhD

This article was originally published on MDMag.com, part of the HCPLive Network.

The US Food and Drug Administration (FDA) has approved an expanded indication for Abbot’s Infinity Deep Brain Stimulation system to target the internal globus pallidus, which plays an integral role in motor function. Targeting this area of the brain may improve symptoms of Parkinson disease.

The approval makes Abbot’s Infinity Deep Brain Stimulation the only directional system approved for all major targets to treat movement disorders, Parkinson disease, and essential tremor, the company said in a statement. The technology provides directed stimulation to areas of the brain and operates on an iOS platform with Bluetooth technology, allowing clinicians to use an iPad to be more efficient in their practice and achieve better outcomes.

"The internal segment of the global pallidus, or GPi, is a well-established valuable DBS target for the management of the motor signs associated with Parkinson's disease, and is a preferred target for many patients, particularly for those with troublesome medication induced dyskinesia," said Jerrold Vitek, MD, PhD, head of the neurology department, director of the Neuromodulation Research Program, and director of the University of Minnesota Udall Center of Excellence for Parkinson's Research, in a statement. "This approval expands the options for patients to tailor treatment to their unique needs, with the added benefits of being able to target precise areas and utilizing a patient-friendly iOS device."

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The platform can seamlessly upgrade to approved capabilities and new features through over-the-air updates.

A clinical study of the device’s performance supports the use of it as an effective way to control symptoms in patients with Parkinson disease and essential tremor. The findings proved that Infinity Deep Brain Stimulation improves quality of life better than just medication alone and improves time without dyskinesias or nonbothersome dyskinesias. The technology sustained improvement for up to 12 months in patients with the disease.

The findings also showed that 9 out of 10 patients with essential tremor were satisfied or very satisfied with the system's ability to control their symptoms. What's more, 98% of patients with essential tremor would recommend the system to someone dealing with tremor.

REFERENCE

ABBOTT receives expanded indication from the US FDA for directional deep brain stimulation system to treat Parkinson's disease [news release]. Abbott Park, Ill: Abbott.

abbott.mediaroom.com/2020-01-24-Abbott-Receives-Expanded-Indication-From-the-U-S-FDA-for-Directional-Deep-Brain-Stimulation-System-to-Treat-Parkinsons-Disease January 24, 2020. Accessed January 24, 2020.