Causalgia

With this new approval, people with a Proclaim™ DRG neurostimulation system can soon receive full-body MRI scans Many doctors consider MRI labeling to be an important factor in the treatment decisions they make for people with chronic pain1 ABBOTT PARK, Ill., Jan. 18, 2024 — Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved expanded MRI labeling for its dorsal root ganglion (DRG) stimulation therapy, the Proclaim™ DRG neurostimulation system, which allows patients to receive full-body MRI scans while implanted with the device.2* The Proclaim DRG neurostimulation system is the only FDA-approved DRG technology, providing targeted relief for people with complex regional pain syndrome (CRPS) types I and II of the lower limbs by stimulating the DRG, which are clusters of nerve cells found along the spine.3 CRPS is a rare and painful condition that affects about 200,000 people in the U.S. each year.4 Characterized by a constant or intermittent burning, stinging or tearing sensation, CRPS has been found to be more excruciating than childbirth or amputation of a limb.5 For people who suffer from the syndrome and struggle to control the pain, Proclaim DRG stimulation can be an effective option, as four out of five people who receive the therapy experience significant pain relief and improved quality of life.6 MRI is one of the most widely used technologies to create detailed images of the inside of the body to inform diagnoses and treatment approaches for people with chronic pain.7 MRIs can be used to help assess the progression of CRPS.8 In these situations, an option like the Proclaim DRG therapy, which allows patients to receive MRI scans anywhere in the body within approved parameters, can be invaluable to the patient and radiologist. "The ability to do full-body MRI scans with the Proclaim DRG neurostimulation system means that, as physicians, we can ensure that people are receiving the care they need in a timely manner because they aren’t having to search for a facility that can accommodate special MRI settings for their device," said Timothy Deer, M.D., DABPM, president and chief executive officer of the Spine and Nerve Centers of the Virginias in Charleston, W.Va. "With these expanded MRI capabilities, we no longer need to sacrifice superior pain relief and quality of life outcomes in exchange for MRI needs." With the expanded MRI labeling, Abbott’s Proclaim DRG neurostimulation system will offer: Full-body scans for new and existing patients^, providing near and long-term flexibility for their imaging needs Safe scanning of any body part with standard MRI scanners^, making finding an imaging center easier and more straightforward for patients and doctors Compatibility with 50cm SlimTip™ DRG leads "As we continue to work holistically across chronic pain care, we’re excited to see this new MRI expanded indication for our proprietary and unique Dorsal Root Ganglion Stimulation therapy become another valuable tool in the hands of treating physicians helping people get back to living a life on their terms," said Pedro Malha, vice president, neuromodulation, Abbott. For U.S. important safety information on the Abbott Proclaim DRG neurostimulation system, visit: https://bit.ly/3SheU6s For U.S. important safety information on Abbott MR conditional systems, visit: https://bit.ly/3vxPs3v *When compared to traditional tonic SCS as seen in the ACCURATE clinical trial. ^Within approved conditions. Refer to the Instructions for Use for full details on the MR Conditional scan parameters. Launch pending. About Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews   1Abbott. Survey on MRI labeling. Completion date: February 1, 2023; Austin, Texas. N = 25. 2 U.S. Food and Drug Administration. See https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150004S063. 3 Abbott. Proclaim™ DRG Neurostimulation System Clinician’s Manual. Plano, TX. 2018. 4 National Organization of Rare Diseases. Feb. 8, 2023. Complex Regional Pain Syndrome. https://rarediseases.org/rare-diseases/reflex-sympathetic-dystrophy-syndrome/. Accessed Nov. 8, 2023. 5 Lee DH, Noh EC, Kim YC, et al. Risk Factors for Suicidal Ideation among Patients with Complex Regional Pain Syndrome. Psychiatry Investig. 2014;11(1):32-38. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3942549/ 6 Deer TR, Levy RM, Kramer J, et al. Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. Pain. 2017;158(4):669-681. https://pubmed.ncbi.nlm.nih.gov/28030470/ 7 Martucci, K., Ng, P., & Mackey, S. (2014). Neuroimaging chronic pain: what have we learned and where are we going?. Future neurology, 9(6), 615–626. https://doi.org/10.2217/fnl.14.57 8 Stanford Medicine. Complex Regional Pain Syndrome (CRPS). https://med.stanford.edu/pain/about/chronic-pain/crps.html Accessed. Nov. 8, 2023.

Abbott's NeuroSphere Virtual Clinic gives patients the flexibility and comfort of receiving care anywhere* by connecting with their doctor via secure in-app video chat and an integrated remote programming feature, now available within the proprietary Abbott patient controller app Abbott Introduces NeuroSphere Virtual Clinic. (Credit: Abbott) Abbott (NYSE: ABT) today announced the U.S. launch of NeuroSphere™ Virtual Clinic, a first-of-its-kind technology that allows patients to communicate with physicians, ensure proper settings and functionality, and receive new treatment settings remotely as needed. Approved by the U.S. Food and Drug Administration, the NeuroSphere Virtual Clinic has the potential to increase access to optimal treatment for patients suffering from chronic pain or movement disorders who don’t live close to a care provider, have difficulty accessing care, or are unable to go to the doctor because of circumstances like COVID-19. Abbott’s NeuroSphere Virtual Clinic gives patients the flexibility and comfort of receiving care anywhere* by connecting with their doctor via secure in-app video chat and an integrated remote programming feature, now available within the proprietary Abbott patient controller app. NeuroSphere Virtual Clinic enables clinicians to prescribe new treatment settings remotely to the patient’s neurostimulation device using the clinician programmer app and a new, simple and secure remote care connection. This advancement gives patients confidence in their care and the convenience to manage their therapy in a way that fits their lifestyle. “With NeuroSphere Virtual Clinic, physicians can communicate and digitally prescribe new stimulation settings remotely, allowing them to extend care beyond their clinic walls and optimize therapy management,” said Timothy Deer, M.D., DABPM, president and chief executive officer of The Spine and Nerve Center of the Virginias in Charleston, W.Va. “This is a significant advancement for chronic pain patients.” “NeuroSphere Virtual Clinic solves considerable issues patients with movement disorders, such as Parkinson’s disease or essential tremor, can have in obtaining the care they need,” said Drew Falconer, M.D., neurologist and director, Inova Parkinson’s and Movement Disorders Center in Fairfax, Va. “Often, patients must be off their medication overnight, so that their treatments can be adjusted properly, which can make it difficult for a patient to travel to their specialist. With NeuroSphere Virtual Clinic, patients can receive stimulation settings from their physicians in real time and remotely via cloud and Bluetooth-based technology, which is something we have never been able to do before. This opens up a world in which patients can receive the care they need anytime, anywhere.”* The NeuroSphere Virtual Clinic can also be helpful for people who live in areas — both rural and urban — with inadequate access to medical services. On average people living with movement disorders will travel over 150 miles to access specialists offering deep brain stimulation (DBS).1 Without alternative solutions, such as digital and/or telehealth options, these patients are more likely to delay or forego much-needed care.2 NeuroSphere Virtual Clinic brings the convenience and flexibility of telemedicine to neurostimulation therapy, further benefitting chronic pain and movement disorder patients with Abbott devices. Medicare will cover remote programming services as a telehealth benefit through the duration of the public health emergency. “A decade ago, we started evaluating the hurdles that patients had to overcome to receive neuromodulation treatment, and we have been working ever since to find a better way to connect providers and patients – with the goal of empowering patients to decide how to access the care they need,” said Keith Boettiger, vice president, Neuromodulation, Abbott. “We are continuing to make these kinds of investments and working with regulatory authorities to make these telehealth changes permanent, as we believe that patients should be able to receive the care they need, regardless of whether they can make it physically to the doctor’s office.” The NeuroSphere Virtual Clinic is compatible with Abbott’s suite of neuromodulation technologies, including Infinity™ DBS System for patients with Parkinson’s disease and tremors of the upper extremities in adults with essential tremors; Proclaim™ XR SCS System for patients living with chronic pain of the trunk and/or limbs; and Proclaim™ DRG Neurostimulation System for patients with chronic pain in the lower limbs caused by complex regional pain syndrome or causalgia. This integration across all Abbott neuromodulation technologies highlights Abbott’s relentless pursuit of patient-centered research and development methodologies that use neuroscience combined with cutting-edge technology to go beyond physical symptom relief to improve the lives of people with neurological disorders. *Anywhere with a cellular or Wi-Fi connection and sufficiently charged patient controller. Source: Company Press Release

Abbott announced today that it has updated NeuroSphere, its app-driven neuromodulation therapy platform, with remote programming capabilities that will allow patients to speak with and receive adjustments from their provider via a cellular or WiFi connection. The NeuroSphere Virtual Clinic was recently approved by the FDA and is now available within the Abbott patient controller app for use with Abbott's 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 medical device company said. WHAT'S THE IMPACT Abbott said the Virtual Clinic enables a secure connection between a patient and practitioner using the corresponding clinician programmer app. With this, patients can discuss the chronic pain and movement disorder neuromodulation treatments with their doctor directly within their controller app, and the provider can subsequently prescribe new stimulation settings from afar through the virtual system. The company said these capabilities would extend the reach of neuromodulation therapies to individuals who live in rural areas, often need to delay care until an appropriate adjustment can be made or otherwise would have difficulty accessing specialist services. "Often, patients must be off their medication overnight, so that their treatments can be adjusted properly, which can make it difficult for a patient to travel to their specialist," Dr. Drew Falconer, director of Inova Parkinson's and Movement Disorders Center, said in a statement provided by Abbott. "With NeuroSphere Virtual Clinic, patients can receive stimulation settings from their physicians in real time and remotely via cloud and Bluetooth-based technology, which is something we have never been able to do before." Remote programming is also a boon during the time of COVID-19, when in-person care is often being postponed due to limited openings and risks of disease exposure. Of particular note is temporary telehealth reimbursement through Medicare, which Abbott said NeuroSphere Virtual Clinic will receive at least until the end of the public health emergency. "A decade ago, we started evaluating the hurdles that patients had to overcome to receive neuromodulation treatment, and we have been working ever since to find a better way to connect providers and patients – with the goal of empowering patients to decide how to access the care they need," Keith Boettiger, vice president of neuromodulation at Abbott, said in a statement. "We are continuing to make these kinds of investments and working with regulatory authorities to make these telehealth changes permanent, as we believe that patients should be able to receive the care they need, regardless of whether they can make it physically to the doctor's office." THE LARGER TREND It was only half a year ago that Abbott launched its patient controller app as a user-friendly replacement for the separate devices patients would need to self-manage their neuromodulation treatments. This approach not only cut down on the number of devices a patient needed to carry around, but still used third-party services to communicate with the provider (a statement within the original announcement for the app's FDA-approval referenced Apple's FaceTime app). More broadly, the newest features and their accompanying reimbursement coverage are also the latest the industry's and government's support of moving care outside of the hospital throughout the pandemic. Notable examples of the latter include the FDA expanding the use of connected vital sign monitors to include remote care, and CMS' "Acute Hospital Care at Home program" and expanded "Hospitals Without Walls" initiatives.