Abbott’s Proclaim Plus Spinal Cord Stimulation System Clenches FDA Approval

The first clinical use of spinal cord stimulation was in 1967 for chronic pain management in cancer patients. A spinal cord stimulator consists of electrodes and a generator which looks like a small battery pack. The electrodes are placed between the vertebrae and the spinal cord (the epidural space), while the generator is positioned under the skin. Earlier, spinal cord stimulators led to discomfort called paresthesia, where the patient would feel a tingle while the electric impulse was given.

The latest technology in spinal cord stimulation has wholly alleviated the concept of paresthesia. Yesterday, Abbott announced that their Proclaim Plus spinal cord stimulation system received approval from the US Food and Drug Administration (FDA).

Demand for Spinal Cord Stimulation in Healthcare

A scientific report by Boston University’s School of Public Health states that one in five people in the world are affected by chronic pain caused by arthritis, cancer and other reasons. In the US, around 50 million individuals suffer from chronic pain, and the healthcare industry’s cost per year on pain management is estimated to be $635 billion. Thus, the need for an effective pain-relieving device is in demand worldwide to ease the challenges people face due to chronic pain.

A range of pain-relieving products has been engineered and developed by Abbott, such as:

• Proclaim XR recharge-free spinal cord stimulation (SCS) system for superior pain relief with a long battery life
• Proclaim dorsal root ganglia (DRG) neurostimulator system to manage difficult-to-treat chronic pain in certain areas of the lower body, such as the hip, groin, knee, ankle, foot and pelvis
• Prodigy magnetic resonance imaging (MRI) SCS system that allows scanning with various medical imaging techniques, including MRI.

An essential feature of the new neurostimulators developed by Abbott is their proprietary BurstDR stimulation technology which is a new spinal cord stimulation waveform that emulates natural firing patterns in the brain. This technology changes the way pain signals travel to the brain and the way those signals are perceived, providing potential relief from physical pain and emotional pain. The SUNBURST clinical trial showed that BurstDR stimulation is superior to tonic stimulation for overall pain.

Abbott also developed a new therapy called FlexBurst360 which was built upon their BurstDR stimulation technology. FlexBurst360 provides pain coverage across up to six areas of the trunk and/or limbs. In addition, FlexBurst360 enables programming that can be adjusted when an individual’s therapeutic needs change.

RELATED: NeuraLace’s Peripheral Nerve Stimulation System Wins FDA Clearance for Chronic Pain

Technology Advancements with the Proclaim Plus Spinal Cord Stimulator

“Spinal cord stimulation has provided tremendous relief for patients suffering from chronic pain. With its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game-changer in this space, helping to not only improve a patient’s ability to perform everyday activities but also relieve the emotional suffering that pain can cause,” said Steven Falowski, MD, Argires Marotti Neurosurgical Associates of Lancaster, Lancaster, PA, in Abbott’s press release.

“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 because of multiple painful areas and evolving pain over time. Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time,” explained Falowski.

Abbott’s Proclaim Plus spinal cord stimulation carries some promising features:

• A long-lasting battery life that can last up to 10 years if used in low-dose mode
• It includes the BurstDR technology, a waveform signal for prolonged relief from physical pain and the emotional response to the pain
• The system guarantees to carry an upgradeable platform
• Abbott’s NeuroSphere Virtual Clinic allows the patient to communicate with a physician using a secure in-app video chat and stimulation settings can be received remotely in real time regardless of location.

“At Abbott, we are deeply committed to advancing the field of neurostimulation, thus 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 yet another testament of that commitment.”