FDA expands Parkinson's disease label for Abbott's Infinity directional DBS device

Abbott announced on Friday that its Infinity deep brain stimulation (DBS) system received expanded FDA approval to include targeting the internal globus pallidus, an area of the brain that plays a key role in motor function and can be targeted with DBS to improve Parkinson's disease symptoms not sufficiently controlled by medication. With the latest indication, the device becomes "the only directional DBS system approved for all major targets used to treat...Parkinson's disease and essential tremor," Abbott noted.

Binith Cheeran, director of medical affairs for Abbott's DBS business, remarked that "the ability to optimise the programming for each individual opens the door for a new standard of care for DBS therapy."

According to Abbott, the device is the "first and only" DBS system for Parkinson's disease and essential tremor operating on an iOS software platform with Bluetooth wireless technology. The system allows clinicians to streamline the programming process with an iPad mini device using Abbott's new Informity programming feature, while patients can discreetly manage their symptoms with an iPod touch controller. The company added that it "continues to advance its Infinity DBS system...supported by data from the PROGRESS study, the largest DBS study for directional lead use in Parkinson's disease."

Abbott gained the Infinity system through its $25-billion purchase of St. Jude Medical in 2017. The device received initial FDA approval in 2016 for the treatment of Parkinson's disease and essential tremor, with the agency later approving a software upgrade for the DBS system that delivers magnetic resonance-conditional labelling.  

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