Proclaim™ Dorsal Root Ganglion (DRG) therapy
A novel neurostimulation technology that targets and relieves pain at the source for patients suffering from complex regional pain syndrome (CRPS Type I) and causalgia (CRPS Type II). Traditional spinal cord stimulation (SCS) therapy has been used safely for decades; however, patients suffering from CRPS I or causalgia don’t always respond well to traditional SCS. Abbott’s Proclaim DRG therapy works differently by stimulating a cluster of nerves along the spine known as the DRG.
The DRG is the control center for peripheral sensory nerves. Amplification of incoming peripheral signals can lead to neuropathic pain. Modulating the DRG enables a reduction in pain and superior outcomes for focal chronic pain from CRPS I or causalgia, conditions that were previously underserved by traditional SCS.
By focusing electrical stimulation specifically on the DRG, we’re able to interrupt pain signals before they reach the spinal cord or brain, so patients don’t feel pain in the same way. Interrupting these pain signals at the source enables the use of low-energy levels and helps eliminate unnecessary stimulation throughout the body, unlike traditional spinal cord stimulation systems.
According to the Centers for Disease Control and Prevention, chronic pain affects more than 50 million Americans, and over a third of those cases are described as “high-impact chronic pain,” which is pain severe enough to limit life or work activities. Research suggests that the economic burden on the healthcare system exceeds $500 billion in direct medical costs, lost productivity and disability.
Abbott’s Proclaim™ DRG therapy is backed by the ACCURATE clinical trial, the largest randomized, head-to-head, controlled neuromodulation trial for the treatment of CRPS I and causalgia to date. ACCURATE showed that patients receiving DRG stimulation achieved superior and sustainable pain relief and quality of life improvements for focal chronic pain when compared to patients receiving traditional SCS. Study findings demonstrated that at 12 months, DRG stimulation reduced pain an average of 81%, and provided persistent pain relief to 86% of patients. Statistically significant improvements in physical function, general health and social function at 12 months were also seen. For over nine years, Abbott’s DRG technology has been studied in diverse settings around the world, including 21 clinical studies, and over 1,000 patients demonstrating positive outcomes in these studies.ii
About the Proclaim DRG Neurostimulation System
Abbott’s Proclaim DRG Neurostimulation System stimulates a spinal target called the dorsal root ganglion (DRG), which contains primary sensory neurons that transmit pain signals from nerves to the brain. Using Bluetooth® wireless technology, iOS software and an intuitive Apple iPod touch mobile digital device as the system’s controller, the Proclaim DRG system is designed to provide patients new benefits over traditional spinal cord stimulation systems. The Proclaim DRG platform is magnetic resonance (MR)-conditional and recharge-free, offering upgradeability and increased battery capacity over Abbott’s previous generation systems. DRG stimulation with the Proclaim system has been shown to be particularly effective for treating pain in areas currently underserved by traditional SCS, such as the groin, lower leg and feet. Abbott’s DRG therapy is approved for use in the U.S., Europe and Australia.
iDeer, 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. Apr 2017;158(4): 669-681. http://dx.doi.org/10.1097/j.pain.0000000000000814 ACCURATE IDE STUDY, St. Jude Medical.
iiAbbott on file.
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