FDA Approves App to Personalize Parkinson’s Disease Therapy via Mobile Device

The U.S. Food and Drug Administration (FDA) has approved the use of Abbott’s Patient Controller app on personal Apple smartphone devices. The app is designed to coordinate therapies that use neuromodulation technology. It allows people using neuromodulation to view, select, and control their own therapy directly from the app.¹

The Patient Controller platform is compatible with different Abbott neuromodulation devices. This includes:¹

• InfinityDBS System for those with PD or essential tremor
• Proclaim XR SCS System for those living with chronic pain
• Proclaim DRG Neurostimulation System for those with chronic pain due to complex regional pain syndrome or causalgia

What is neuromodulation therapy?

Neuromodulation therapy is used for a variety of conditions, including PD. The therapy works by altering nerves with electrical or chemical stimulation. It involves applying electrodes to the brain, spinal cord, or peripheral nerves. These leads connect via an extension cable to a pulse generator and power source. This then generates the electrical stimulation. An electrical current goes from the generator to the nerve. This can either block pain signals or stimulate neural impulses that would not occur otherwise.²

What are the benefits of the Patient Controller App?

The Patient Controller app allows people who get neuromodulation therapy to manage their own therapy regimens with their mobile devices. Supported devices include certain models of iPhones and iPods. The app then syncs with the NeuroSphere Digital Care platform. It also includes FaceTime, which allows the user to communicate directly with their doctor or care team.¹

The app lets people who get this kind of therapy monitor their care without having to leave home. It also eliminates the need for people to carry a separate programming device with them. These are important factors for people who have issues with their mobility or cannot carry multiple devices. The app also allows the therapy to be given without disruption to a person’s typical schedule.¹

During the COVID-19 pandemic, this is important for people who are at risk for various reasons. It is also helpful for those who want to shelter-in-place as much as possible in order to reduce their risk. This app allows them to access needed medical treatment while staying in the comfort of their own home.¹

Things to know about the Patient Controller App

If you do not have an Apple iPhone, this app is not formulated for any other smartphone yet. Before getting an iPhone to replace your current programming device, talk with your doctor about your therapy and whether this is the right option for you.

The Patient Controller App should not be used by people who are unable to operate it or those who have had an unsuccessful test stimulation. People using the app on a personal Apple iOS device should know how to perform these basic functions:³

• Turning the patient controller on and off
• Placing the patient controller in sleep mode
• Waking the patient controller from sleep mode
• Locking and unlocking the patient controller
• Using touchscreen functions such as tap and screen swipe
• Returning to the Home screen

You must download the Patient Controller App to your patient controller in order to use the patient controller with your generator. This may be either a device provided by Abbott Medical or a compatible personal Apple iOS device. Once the app is installed, users should regularly check for app updates in Apple’s online App Store.³

Certain mobile devices and operating systems have been tested for compatibility with the Patient Controller App. People using Abbot neuromodulation devices should review the compatibility guide before installing the app.³

For more information, read the Patient Controller User’s Guide.