Abbott announces it has received FDA approval for a new, expanded indication for its 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 reportedly 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, the company notes in a media release.
The DBS system is designed to operate in these indications on an iOS software platform with Bluetooth wireless technology. Clinicians can streamline the programming process with an iPad mini device using Abbott’s new Informity Programming feature, and 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,” says Jerrold Vitek, MD, PhD, 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, in the release.
“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 optimize patient outcomes and limit side effects. The platform’s 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 supported by data from the PROGRESS study for directional lead use in Parkinson’s disease.
“Abbott’s PROGRESS study has led the way in establishing the value of directional DBS systems for targeted areas of the brain,” Binith Cheeran, MD, director of medical affairs, deep brain stimulation, a part of Abbott’s neuromodulation business, notes in the release.
“The approval of Abbott’s Infinity DBS system with targeted stimulation is a significant advancement for people living with Parkinson’s disease and their care teams. The ability to optimize the programming for each individual opens the door for a new standard of care for DBS therapy.”
[Source(s): Abbott, PR Newswire]