FDA Approves Abbott’s New Spinal Cord Stimulation Device; Provides tailored relief for multiple pain areas and adds more treatment options for evolving pain conditions

  • Abbott’s new Proclaim™ Plus spinal cord stimulation (SCS) system offers the next generation of stimulation therapy, giving clinicians the ability to treat pain in multiple locations and in development.
  • The system is based on the company’s proprietary therapy, BurstDR™ stimulation, which works by mimicking the natural patterns found in the brain1 to provide superior pain relief2,3 and is preferred over traditional tonic “pain” stimulation by 87% of patients4
  • The Proclaim Plus SCS System can be used in conjunction with Abbott’s NeuroSphere™ Virtual Clinic, which allows people to connect with their doctor and receive remote programming adjustments from the comfort of their own home*

ABBOTT PARKSick., August 23, 2022 /PRNewswire/ — Abbott (NYSE: ABT ) announced today that the US Food and Drug Administration (FDA) has approved its new Proclaim™ Plus Spinal Cord Stimulation System (SCS) featuring FlexBurst360™ therapy. The next generation of Abbott’s proprietary BurstDR™ stimulation, FlexBurst360 therapy provides pain coverage in up to six areas of the trunk and/or limbs and enables programming that can be adjusted as a person’s therapeutic needs evolve.

Designed to adapt to a person’s life, the Proclaim Plus SCS system is rechargeable with a battery that can last up to 10 years.^ It can be used with Abbott’s NeuroSphere™ Virtual Clinic connected care technology, which allows a person to communicate both with a doctor via secure in-app video chat and remotely receives real-time stimulation settings regardless of location.*

More than 50 million people in the US suffer from chronic pain5 and 88% of them have pain in at least two or more different areas of their body.6 SCS therapy, also known as neurostimulation, is an implanted device that sends mild electrical pulses to nerves along the spinal cord, changing the way the body perceives pain signals, which can relieve chronic pain and improve quality of life. life. According to the American Pain Foundation, chronic pain is the leading cause of doctor visits and costs the nation approx. 635 billion dollars each year in health care costs, disability and lost productivity.7

“Spinal cord stimulation has provided tremendous relief to patients suffering from chronic pain. With its ability to mimic the natural patterns found in the brain, the Abbott BurstDR platform has been a game changer in this space, helping not only to improving the patient’s ability to perform daily activities but also relieve emotional suffering§ it can cause pain”, he said Steven FalowskiMD, Argires Marotti Neurosurgical Associates of Lancaster, Lancaster, Pa. “However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened by pain due to multiple painful areas and pain that evolves over time. Now, with Proclaim Plus and FlexBurst360, an already established Platform has been enhanced to treat more patients suffering from pain in different parts of the body and pain that changes over time.”

BurstDR therapy is Abbott’s exclusive stimulation technology that delivers pulses—or bursts—of mild electrical energy to alter pain signals as they travel from the spinal cord to the brain. Clinical studies have shown that BurstDR technology provides superior pain relief compared to tonic stimulation3it improves people’s daily lives and reduces emotional suffering§ associated with pain.4 When compared to standard tonic stimulation technology, which provides a constant tingling sensation from the patient, 87% of people preferred BurstDR technology, which provides pain relief in a sub-sensory range that is not felt by the patient.4

By using FlexBurst360 therapy in the Proclaim Plus system, clinicians can identify the lowest effective dose of stimulation for each patient and tailor it based on evolving pain needs. The system allows clinicians control over multiple independent BurstDR stimulation zones to provide broader pain coverage without the risk of overstimulation.8

The Proclaim Plus System with FlexBurst360 Therapy is designed to fit seamlessly into a person’s life, and therapy settings can be accessed using a personal mobile device** or via an Abbott-supplied mobile device. Patients can use the same device to access Abbott’s proprietary NeuroSphere Virtual Clinic, a first-of-its-kind neurostimulation technology9 in the US that allows patients to communicate with doctors, ensure their device is working properly, and receive remote adjustments to their therapeutic parameters as needed.

“At Abbott, we are deeply committed to advancing the field of neurostimulation, helping people address the challenges they face while managing their chronic pain,” said Pedro Malha, vice president, neuromodulation, Abbott. “Our latest development, Proclaim Plus with FlexBurst360 therapy, is further evidence of this commitment.”

* Anywhere with a cellular or Wi-Fi connection and a sufficiently charged patient controller.
^Up to 10 years battery life at lowest program setting: 0.6 mA, 500 Ohms, duty cycle 30 seconds on/360 seconds off, BurstDR stimulation in one zone. Refer to the IFU for additional information.
§ Pain and suffering measured with the visual analogue scale.
**For a list of compatible devices: https://www.neuromodulation.abbott/us/en/mobile-device-os-compatibility.html.
For important US safety information on Abbott Proclaim Plus with FlexBurst360, visit: https://www.neuromodulation.abbott/us/en/important-safety-info.html.

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 healthcare spectrum, with leading businesses and products in diagnostics, medical devices, foods and branded generic drugs. Our 113,000 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.

1 De Ridder D., Vanneste, S., Plazier, M., & Vancamp, T., (2015). Mimicking the brain: Evaluation of the St. John’s Prodigy Chronic Pain System. Jude Medical with Burst technology. Medical Device Expert Review, 12(2), 143-150.
2 Dreri T, Slavin KV, Amirdelfan K, etc. Success in the use of neuromodulation with BURST (SUN): Results from a prospective, randomized controlled trial using a novel burst waveform. Neuromodulation. 2017.
3 Karri J, Joshi M, Polson G, Tang T, Lee M, Orhurhu V, et al. Spinal Cord Stimulation for Chronic Pain Syndromes: A Review of Considerations in Practice Management. Pain doctor. November 2020; 23 (6): 599-616.
4 Dreri, T. Randomized, controlled trial evaluating burst stimulation for chronic pain: 2-year results from the SUNBURST study. Presented at NANS 2018.
5 Yong RJ, Mullins PM, Bhattacharyya N. Prevalence of chronic pain among adults in United States. Pain. 2022 February 1;163(2):e328-e332.
6 Eldabe S, Kumar K, Buchser E, Taylor RS. An analysis of components of pain, function, and health-related quality of life in patients with failed back surgery syndrome treated with spinal cord stimulation or conventional medical management. Neuromodulation 2010; 13:201-209.
7 American Pain Foundation. Chronic Pain Facts. https://uspainfoundation.org/pain/. Accessed June 27, 2022.
8 Falowski. Use of intraoperative neuromonitoring to program multiple areas of burst spinal cord stimulation for the treatment of chronic pain. Poster presented at ASPN 2022.
9 Abbott. Data in the file. MAT-2101330 v1.0.


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