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NewswireTODAY - /newswire/ -
Charleston, SC, United States, 2014/04/08 - Clinical Trials of SouthCarolina announced today that the site will participate in a U.S. pivotal clinical study aimed at establishing the safety &efficacy of the investigational Axium™ Neurostimulator System for patients with chronic lower limb pain.
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Every year, millions of Americans are affected by chronic neuropathic pain, impacting their ability to lead productive working, social and family lives. Neuropathic pain is induced by an injury or disease of the nervous system such as Complex Regional Pain Syndrome (CRPS). Another common cause is chronic post-surgical pain, which affects up to 35 percent of patients who undergo hernia surgery and 50 to 85 percent of patients who undergo amputations . Patients suffer from a wide variety of pain sensations including stabbing, burning, pins and needles, and numbness, and few long-term treatment options exist.
The Axium Neurostimulator System (developed by Spinal Modulation, Inc. of Menlo Park), is a small implanted device that delivers stimulation to a specific branch in the spinal cord called the Dorsal Root Ganglion (DRG). The DRG processes pain signals as they travel to the brain and plays an important role in the development and maintenance of chronic pain. By stimulating the DRG, the Axium System interrupts pain signals before they travel to the brain. While this therapy is approved throughout Europe and Australia, the device is for investigational use only in the U.S.
“Chronic lower limb pain can be debilitating and all-consuming, as it significantly impacts a patient’s ability to participate in normal, everyday activities. Lower limb pain such as in the foot, leg, and groin is particularly challenging to treat as many of the current therapies have difficulty targeting specific anatomical areas,” said Dr. Edward Tavel Jr., M.D., the Principal Investigator and Medical Director of Clinical Trials of South Carolina. “The Axium system leverages an established approach - spinal cord stimulation - but addresses the DRG, which is a promising target for the treatment of chronic pain. The clinical data reported with Axium internationally are encouraging because 78 percent of participants experienced pain relief in the lower limbs. We are excited that Clinical Trials of South Carolina was selected to participate in the ACCURATE Study and contribute to important research in the U.S."
To qualify for the ACCURATE Study, participants must be between the ages of 22 and 75, have had chronic pain affecting lower limbs for at least 6 months and have not seen lasting success with other treatments or previously used spinal cord stimulation for chronic pain.
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