Abbott receives expanded indication from FDA for directional DBS to treat Parkinson’s disease

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Abbott has announced it received approval from the US Food and Drug Administration (FDA) for a new, expanded indication for the company’s Infinity deep brain stimulation (DBS) system to include targeting of an area of the brain called the internal globus pallidus (GPi). The GPi plays an integral role in the motor function and can be targeted with DBS to improve the symptoms of Parkinson’s disease not adequately controlled by medication.

With this approval, Abbott’s Infinity DBS is now the only directional DBS system approved for all major targets used to treat movement disorders, Parkinson’s disease and Essential Tremor: the subthalamic nucleus (STN), ventral intermediate nucleus (VIM) and GPi. According to the company, it is the world’s first and only DBS system operating in these indications on an iOS software platform with Bluetooth wireless technology. Clinicians are able to streamline the programming process with an iPad mini device using Abbott’s new Informity Programming feature to become more efficient in their practice and achieve optimal outcomes with directional leads. Moreover, patients can discreetly manage their symptoms with their Infinity DBS System iPod touch controller.

“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, head of the Neurology Department, director of the Neuromodulation Research Program, and center director of the University of Minnesota Udall Center of Excellence for Parkinson’s Research. “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.”

Abbott’s Infinity DBS system with directional leads provides directed stimulation to areas of the brain to optimise patient outcomes and limit side effects. The platform’s future-ready technology has the ability to seamlessly upgrade the approved capabilities and new therapy features of the Infinity DBS system through simple, over-the-air updates.

“Abbott’s PROGRESS study has established the value of directional DBS systems for targeted areas of the brain,” noted Binith Cheeran, director of medical affairs, deep brain stimulation, a part of Abbott’s neuromodulation business.

Abbott’s Infinity DBS system also has CE Mark and is available in nearly 30 countries.


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