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Abbott Earns FDA Approval for iOS App to Manage Personalized Neuromodulation Therapy

app by Abbott

The U.S. Food and Drug Administration (FDA) has approved a new app developed by Abbott, called the Patient Controller app, which will allow patients with chronic neurological conditions to manage personalized therapy regimens using compatible smartphones.

The Patient Controller app, which is compatible with Apple’s operating system iOS, synchronizes with Abbott’s NeuroSphere Digital Care, a platform designed to coordinate therapies that involve neuromodulation technology.

Neuromodulation is a therapeutic process in which nerves are directly altered via electrical or chemical stimulation.

Abbott currently offers three neuromodulation therapy systems: Infinity DBS for patients with Parkinson’s disease or essential tremorProclaim XR SCS for patients with chronic pain; and Proclaim DRG Neurostimulation for patients with lower limb pain caused by complex regional pain syndrome or causalgia.

For patients with Parkinson’s, the Infinity DBS system provides a therapeutic technique called deep brain stimulation, in which an electrical impulse is fired at targeted neurons to counteract involuntary motor symptoms, such as tremors.

The Patient Controller app eliminates the need for a separate device to program the therapies offered by these systems, allowing a greater integration of these treatments into a patient’s daily life.

“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,” Keith Boettiger, vice president of neuromodulation at Abbott, said in a  press release.

The app features an easy-to-use interface that can incorporate FaceTime calling on iOS devices, allowing patients to control not only the neuromodulation therapy, but also communicate with their healthcare provider in real time.

This capability is particularly useful during the COVID-19 pandemic, as neuromodulation requires close monitoring of patient progress, and any technology that facilitates remote treatment is invaluable in reducing the risk of viral transmission.

“For physicians who are prescribing and implanting neuromodulation technologies, the ability to integrate therapies into one’s everyday life is key,” said Alexander Escobar, MD, a clinical assistant professor at the University of Toledo, Ohio.

“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,” Escobar said. “Physicians have the ability to remain engaged with their patients through the Apple device, allowing them to interact and treat debilitating chronic pain.”

Furthermore, as patients with Parkinson’s and other chronic conditions may have limited mobility, the Program Controller app offers greater accessibility to treatment.

“The ability to support the changing needs of individuals living with debilitating chronic conditions, like Parkinson’s, without them having to leave their homes is vitally important in today’s world,” said Drew Falconer, MD, director of the Parkinson’s and Movement Disorders Center in the Inova Health System in Virginia.

“Abbott’s NeuroSphere Digital Care solution, including the new Patient Controller app, allows patients to handle one single device and using the FaceTime application, interact with their provider teams in a convenient, easy-to-use interface — an important attribute for those with tremors or have challenges with mobility,” Falconer said.

Abbott said the app will be available in a few weeks. You can visit this website to learn which Apple mobile digital devices are compatible with the app.

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FDA Extends Abbott’s Infinity DBS System Approval to Target Additional Brain Region

Infinity DBS system

The U.S. Food and Drug Administration (FDA) has expanded Abbott’s Infinity Deep Brain Stimulation (DBS) system approval to target a brain region critical for motor functions — the globus pallidus — as a way to lessen motor symptoms in Parkinson’s disease patients who still show impairments after medication.

This extended approval makes Abbott’s Infinity the only directional DBS system approved to target all three main brain regions used to treat Parkinson’s, essential tremor and movement disorders: the globus pallidus, the subthalamic nucleus, and the ventral intermediate nucleus.

DBS is an invasive surgical technique in which thin wires are implanted in the brain to deliver electrical pulses to certain areas. It is intended to ease motor symptoms in patients for whom standard medications, such as levodopa, are not effective, and stave off long-term motor complications, including tremors and dyskinesia (involuntary movements).

Traditional DBS systems are “omnidirectional,” meaning they don’t target specific parts of the brain. Abbott’s DBS system differs from others in that it’s designed to steer electrical current toward specific parts of the brain to lessen symptoms such as tremors.

Because the stimulation is more targeted, patients should be able to get meaningful symptom relief with less stimulation.

“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,” Jerrold Vitek, MD, PhD, said in a press release. Vitek is director of the University of Minnesota Udall Center of Excellence for Parkinson’s Research, .

The Infinity DBS system uses a wireless Apple consumer device that allows doctors to perform upgrades and optimize programming settings without the need for surgery. Patients also are able to control their Infinity DBS System via a wireless touch controller.

“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,” Vitek said.

The ongoing PROGRESS trial (NCT02989610) is evaluating Abbott’s Infinity DBS system for treating Parkinson’s. The trial’s primary goal is to compare the therapeutic effectiveness of the Infinity DBS system compared to a conventional omnidirectional system.

Preliminary results from 66 Parkinson’s patients evaluated after three months of using the Infinity DBS system showed that most (89.4%) had a wider therapeutic window — an average increase of 35% — accompanied by an average decrease of 30% in the amount of stimulation needed to attain a therapeutic effect, compared with patients who were using a conventional omnidirectional system.

“Abbott’s PROGRESS study has led the way in establishing the value of directional DBS systems for targeted areas of the brain,” said Binith Cheeran, MD, director of medical affairs, deep brain stimulation, at Abbott.

“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,” he said.

Abbott’s Infinity DBS system is available in nearly 30 countries.

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Abbott Partners with NIH on BRAIN Initiative to Use Neuromodulation Technologies

Abbott BRAIN NIH

Abbott is partnering with the National Institutes of Health (NIH) to explore the use of its neuromodulation technologies for treating chronic pain and progressive movement disorders, including Parkinson’s disease.

The partnership’s goal is to drive forward the Brain Research through Advancing Innovative Neurotechnologies initiative, known as BRAIN, which is working to accelerate neuroscience research.

With this collaboration agreement, Abbott will make its proprietary neuromodulation technologies available for research purposes. These include directional deep brain stimulation (DBS), spinal cord stimulation (SCS), and dorsal root ganglion (DRG) therapy, which have already been shown to be beneficial in treating several conditions affecting the central nervous system.

Researchers will now be able to explore ways to use these technologies to fill knowledge gaps in the field of neuroscience and, at the same time, find new strategies to apply them to treat chronic and progressive neurological disorders.

“The NIH is investigating the application of these devices for the treatment of a wide range of neurological and neuropsychiatric conditions and chronic pain,” Nick B. Langhals, PhD, program director for neural engineering in the division of translational research at the National Institute of Neurological Disorders and Stroke (NINDS), said in a press release.

“The neuromodulation technologies provided by Abbott will help us determine the inner workings of the nervous system to help fill gaps in our current knowledge of the brain and provide opportunities for exploring how the brain interacts with the human body in patients with neurological conditions,” Langhals added.

The  BRAIN initiative, launched in 2013, seeks to understand how the human brain works, especially in a context of disease, by taking advantage of innovative technologies. It also is working to establish new “out-of-the-box” applications for currently available technologies. Its goal is to show how individual cells and complex neural circuits interact in both time and space.

To date, the BRAIN initiative has gathered partners and contributors from diverse backgrounds, including federal agencies, public organizations, Congress, and even the media.

“Researchers at Abbott are continuously striving to better understand how neuromodulation technology can benefit people living with chronic pain or movement disorders,” said Keith Boettiger, vice president of neuromodulation at Abbott. “In addition to our own research efforts, including clinical and real-world studies, working together with world-class scientists at the NIH will help us further validate our neuromodulation therapies and explore new avenues where they may benefit patients affected by devastating neurological conditions.”

With the support of NINDS and the BRAIN initiative, researchers have developed an experimental DBS system that uses brain signals to fine tune its activity in response to signs of dyskinesia, or uncontrolled body movement. This approach may potentially represent a more refined way to ease motor problems in Parkinson’s patients.

During the 5th Annual BRAIN Initiative Investigators Meeting, recently held in Washington, D.C., partners from the BRAIN initiative discussed scientific advancements in the neuroscience field, and identified areas for collaboration and research coordination. 

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