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Most patients treated with SPR Therapeutics' 60-day PNS therapy achieved clinically significant reductions in pain intensity, disability and pain interference.
October 10, 2019
By: Globe Newswire
SPR Therapeutics Inc., a developer of neurostimulation technology for pain management, has presented interim results on the safety and effectiveness of the SPRINT Peripheral Nerve Stimulation (PNS) System when used for the treatment of chronic low back pain. Interim data on the subset of patients taking opioids demonstrated that percutaneous PNS delivered by the SPRINT System for up to 60 days can significantly reduce usage of opioid medication in patients with low back pain. The results also support earlier findings that SPRINT can relieve chronic low back pain, leading to improvement in quality of life and reduction in disability, without a permanently implanted device. Among the cohort of patients with chronic low back pain who were taking opioids, a majority experienced substantial (≥ 50 percent) reductions in opioid consumption both during treatment and for at least three months following PNS treatment with the SPRINT PNS System. These substantial reductions were seen even among patients with daily baseline opioid consumption ≥ 50 milligram morphine equivalent (rated by the CDC as high-risk for opioid overdose). The reductions in opioid analgesic consumption reported were coupled with clinically significant reductions in average pain intensity, disability, and pain interference. View data here. “We continue to be encouraged with the positive outcomes being achieved with SPRINT PNS when used for chronic low back pain,” said Tim Deer, M.D., SPRINT PNS study investigator and president and CEO of the Spine and Nerve Centers of the Virginias. “While these are interim data on a subset of the patients, these latest findings further validate the potential of the SPRINT PNS System to reduce opioid use and the need for a permanently implanted device providing a treatment option that should be considered early in the care pathway.” The SPRINT Peripheral Nerve Stimulation (PNS) System is the only percutaneous PNS device that is cleared by the U.S. Food and Drug Administration (FDA) for up to 60 days in the back and/or extremities for both chronic and acute pain, including post-operative and post-traumatic pain. The SPRINT PNS System works by implanting a thin leadwire, the MicroLead, typically under image-guidance, to target a peripheral nerve. The MicroLead is connected to a wearable device that sends small electrical pulses to the nerve for up to 60 days after which time the lead is withdrawn. In multiple studies, the SPRINT PNS System has demonstrated the ability to deliver effective and sustained improvements in pain and function after the MicroLead has been withdrawn. Physicians have prescribed the SPRINT system to treat post-amputation pain, end-stage knee and shoulder joint pain, chronic low back pain, complex regional pain syndrome (CRPS), and post-operative pain following joint replacement and surgical reconstruction (partial listing). Several post-market clinical trials are underway. SPR Therapeutics Inc. is a privately-held medical device company that develops, manufactures, and commercializes non-opioid, minimally invasive, neurostimulation device treatment options that improve quality of life. The company is headquartered in Cleveland, Ohio, with additional offices in Maple Grove, Minn., and Chapel Hill, N.C.
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