Abbott app replacing neuromodulation system controllers receives FDA approval

The Patient Controller app works with Abbott's Infinity DBS System, Proclaim XR SCS System and Proclaim DRG Neurostimulation System.
By Dave Muoio
02:56 pm

Abbott has received FDA approval for a neuromodulation system-controller app that runs on iOS devices, the company announced Thursday.

Compatible with Abbott's broader NeuroSphere Digital Care platform, the Patient Controller app replaces the separate device patients use to adjust the company's neuromodulation products. These include the Infinity DBS System for Parkinson's disease or essential tremor, the Proclaim XR SCS System for chronic pain and the Proclaim DRG Neurostimulation System for chronic pain in lower limbs due to the complex regional-pain syndrome of causalgia.

The Patient Controller app will be available "in the coming weeks," the company said. According to its website, the app will run on iPhone 6 or new smartphones, as well as on sixth- and seventh-generation iPods.


Ditching the controller for a smartphone app removes at least two burdens patients managing chronic illness face.

On one hand, it's one less device that individuals need to keep on their person when self-delivering neuromodulation therapy. On the other, it provides discretion for system users who might be self-conscious about adjusting the treatment while around others.

“For physicians who are prescribing and implanting neuromodulation technologies, the ability to integrate therapies into one's everyday life is key," Dr. Alexander Escobar, clinical assistant professor of anesthesiology and pain medicine at The University of Toledo, Ohio, said in a statement provided by Abbott.

"The COVID-19 global health crisis has demanded access to virtual treatment options, especially for those individuals with chronic medical conditions [who] may have difficulty coming to see their physician or would prefer not to leave their own home. To ensure our patients are receiving the care they need in the appropriate setting, close follow up is critical. Physicians have the ability to remain engaged with their patients through the Apple device, allowing them to interact and treat debilitating chronic pain.”


The last update on Abbott's neuromodulation offerings came about six months ago, when the company expanded the indication for the Infinity DBS system to include stimulation for Parkinson's disease symptoms. And outside of neuromodulation, the company had ditched a separate controller for its popular Abbott Freestyle Libre diabetes management platform in favor of a companion app back in late 2018.

Also of particular note is a 2019 De Novo clearance granted to Israel-based Theranica for a smartphone-controlled neuromodulation device for acute treatment of migraine.


“Patients are seeking digital options to better engage with their healthcare providers and manage their chronic conditions remotely – and this has never been more evident than in today’s pandemic where virtual care is necessary,” Keith Boettiger, VP of neuromodulation at Abbott, said in a statement. “The approval of Abbott’s Patient Controller app with personalized access to therapy is a landmark event, as we are now able to provide patients a way to access personalized therapy from a compatible and secure iOS device so that people can live their lives and seamlessly manage conditions like chronic pain and movement disorders."


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