This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. This neurostimulation system is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain. The system is intended to be used with leads and associated extensions that are compatible with the system. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Read this section to gather important prescription and safety information. The company claims it is the only medical device manufacturer in the world to offer radiofrequency ablation (RFA), SCS, and DRG stimulation therapy solutions for the treatment of chronic pain.Spinal Column Stimulation (SCS) PRESCRIPTION AND SAFETY INFORMATION Jude, chronic pain affects approximately 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. It is an investigational device in the U.S. The Axium system has been granted a CE Mark in the European Union for the management of chronic intractable pain, and TGA approval in Australia for the management of chronic, intractable pain of the trunk and/or limbs. The Axium device consists of two parts: a pulse generator implanted in the buttocks or abdomen, and up to four wires (leads) that have one end attached to the pulse generator, and the other end secured to the tissue near the target treatment area. The company uses the Axium system developed by Spinal Modulation, Inc., which it recently acquired, to conduct the DRG stimulation trial. Unlike traditional SCS therapy, which targets nerves along the spinal cord’s dorsal column, DRG stimulation offers selective targeting of pain areas, with fewer side effects, such as paresthesias. By stimulating this structure, pain signals can be blocked before they are transmitted to the spinal cord and processed in the brain. Jude is using the multi-center ACCURATE clinical trial to support its PMA application for FDA approval of DRG stimulation for those diagnosed with CRPS or peripheral causalgia, two of the many chronic pain conditions currently underserved by traditional SCS therapy.ĭRG stimulation is a chronic pain management technique targeting the dorsal root ganglion – a cluster of sensory neurons that serve as a conduit of pain signals from the peripheral nervous system to the central nervous system. study reflect last year's presentation of 20 international, peer-reviewed scientific abstracts from Australia and Europe highlighting positive clinical outcomes of the Axium system for the treatment of chronic, intractable pain. “We look forward to continuing to develop DRG stimulation therapy to expand availability for patients currently underserved by traditional chronic pain therapy options.” “Data from the ACCURATE study are exciting because they demonstrate that DRG stimulation can offer meaningful improvement over traditional spinal cord stimulation for patients suffering from chronic pain conditions that have historically been challenging to treat,” said Mark Carlson, M.D., chief medical officer at St. They also reported feeling less stimulated outside their area of pain, demonstrating the precision of DRG stimulation. Participants also reported no differences in the intensity of paresthesias due to postural changes - a common side effect of traditional SCS therapy - while using the Axium system during the three-month trial. The Axium system stimulates the dorsal root ganglion (DRG) for more selective targeting of pain areas that are hard to reach, like the groin, lower leg, and foot.Īccording to a press release, the ACCURATE study showed that DRG stimulation using the Axium system was better than traditional SCS (81.2 vs 55.7 percent) in providing pain relief. Follow me on Twitter Jude Medical is touting positive results of a clinical trial that demonstrated the effectiveness of its Axium Neurostimulator System over traditional spinal cord stimulators (SCS) to relieve the chronic lower limb pain associated with complex regional pain syndrome (CRPS) or peripheral causalgia (nerve damage).
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