FDA Approves App for Personalized Neuromodulation Control

Alexander Escobar, MD

Abbott announced that the FDA has approved the company’s Patient Controller app which allows patients living with neurological conditions, including chronic pain or movement disorders, the ability to manage their neuromodulation-based therapy directly from their personal smartphone.¹

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

The app’s unique build eliminates the need for patients to carry a separate programmer device, ultimately streamlining the patient’s experience and seamlessly integrating therapy management right to their phone. It will be integrated into Abbott’s broader NeuroSphere Digital Care connected care management platform, which became available in May.

Abbott will also integrate the app across all of their neuromodulation technologies, allowing physicians to easily treat the individual needs of each patient within their practice who have an Abbott device and Apple smartphone. Those neuromodulation technologies include the Infinity DBS (deep brain stimulation) system for patients with Parkinson disease (PD) or essential tremor, Proclaim XR SCS System for patients living with chronic pain, and Proclaim DRG Neurostimulation System for patients with chronic pain in the lower limbs caused by complex regional pain syndrome or causalgia.

The FDA originally granted approval for an over-the-air software upgrade for all of the Infinity DBS systems to allow for magnetic resonance (MR)-conditional labeling, among other features, for patients with PD and essential tremor in August 2018. The upgrade also enabled physicians to use Apple hardware to “tune” each patient’s treatment for specific activities through Abbott’s Informity Programming Software.²

In January 2020, the FDA approved an expanded indication for the DBS system to target the internal globus pallidus, which plays a key role in motor function. At the time, the approval made it the only directional system approved for all major targets to treat movement disorders, PD, and essential tremor.³

Escobar also added, “The COVID-19 global health crisis has demanded access to virtual treatment options, especially for those individuals with chronic medical conditions that 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.”

REFERENCES

1. Abbott receives FDA approval for IOS-compatible app allowing people living with chronic pain and movement disorders to personalize therapy via their mobile device [News release]. Abbott Park, Ill: Abbott. Published July 23, 2020. Accessed July 23, 2020. prnewswire.com/news-releases/abbott-receives-fda-approval-for-ios-compatible-app-allowing-people-living-with-chronic-pain-and-movement-disorders-to-personalize-therapy-via-their-mobile-device-301098105.html

2. Abbott expands its directional deep brain stimulation therapy by offering new MR-conditional labeling [press release]. Abbott Park, IL: Abbott; August 2, 2018. Accessed July 23, 2020. abbott.mediaroom.com/2018-08-02-Abbott-Expands-its-Directional-Deep-Brain-Stimulation-Therapy-by-Offering-New-MR-Conditional-Labeling.

3. 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. Published January 24, 2020. Accessed January 24, 2020. 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