Findings show marked reductions in need for opioids and therapeutic lumbosacral spine injections five years post-procedure
MINNEAPOLIS – September 12, 2023 – Relievant Medsystems, a company dedicated to transforming the diagnosis and treatment of vertebrogenic low back pain, today announced the publication of a pooled analysis from three prospective clinical trials that demonstrates the impact of the company’s Intracept® Procedure on significantly reducing the long-term utilization of additional treatments for low back pain. The analysis was published in Pain Medicine, the official journal of the American Academy of Pain Medicine (AAPM).
Through five years post-Intracept Procedure, patients with vertebrogenic pain experienced significant reductions in their need for opioids and therapeutic lumbosacral spine injections following treatment. This includes a 70% reduction in active opioid use compared to use at baseline as well as a 65% reduction in therapeutic lumbosacral spine injections through five years.
Other key findings from the analysis include:
- At five years, the rate of fusion surgery was low (6.5%) and less than half the published rate of 14% at 6 months[1] in patients with chronic low back pain and degenerative disc disease
- 65% of additional pain interventions and surgeries over the 5-year follow-up were performed for treatment of other pain sources
“The societal-level magnitude of disability associated with chronic low back pain cannot be overstated, and this condition has a profound economic impact on our healthcare system,” said Dr. Zachary L. McCormick, lead author of the study, Vice Chair, and Chief of Spine and Musculoskeletal Medicine at the University of Utah School of Medicine in the Department of Physical Medicine and Rehabilitation. “Our previous findings validated basivertebral nerve ablation as an effective and durable treatment option for patients with vertebrogenic pain. The present study specifically focused on how this procedure impacts the low back pain-care paradigm in the years that follow treatment with basivertebral nerve ablation. We expected to observe a decreased need for low back pain-related healthcare utilization, but we did not anticipate just how dramatic the reduction appears to be.”
In the U.S. alone, 30 million adults experience chronic low back pain, leading to approximately 52 million physician visits annually. Individuals with moderate and high impact chronic low back pain had annual per person reported healthcare expenditures of $9,657 and $14,661, respectively.[2]
Relievant Medsystems’ minimally invasive Intracept Procedure is the only FDA-cleared treatment for chronic vertebrogenic low back pain. The same-day, outpatient procedure uses targeted radiofrequency energy to stop the basivertebral nerve (BVN) from transmitting pain signals to the brain and takes approximately one hour to perform. Recovery time varies from patient to patient but most experience little post-procedure pain and generally quick recovery times. Patients often start to feel pain relief within two weeks after the procedure.
“More than 15,000 patients have now been treated with the Intracept Procedure and this analysis demonstrates its crucial role in providing pain relief and eliminating the need for future treatments,” said Tyler Binney, President and CEO of Relievant Medsystems. “As we continue in our mission to transform the diagnosis and treatment of vertebrogenic pain, we look forward to helping patients achieve a better quality of life and making our healthcare system more efficient for everyone it serves.”
For more information on the Intracept Procedure, visit: https://www.relievant.com/intracept/.
About Vertebrogenic Pain
Of the 30 million people in the U.S. with chronic low back pain, 1 in 6 are likely to have vertebrogenic pain, a distinct type of chronic low back pain caused by damage to vertebral endplates, the interface between the disc and the vertebral body. Patients typically have pain in the middle of their low back, which worsens when they bend over, sit for long periods of time, or when they are active. A physician can confirm a patient’s pain is vertebrogenic by observing Modic changes, a biomarker seen on standard MRI that indicates inflammation at the vertebral endplate.
About Relievant Medsystems
Relievant Medsystems is a commercial-stage medical device company transforming the diagnosis and treatment of vertebrogenic pain, a form of Chronic Low Back Pain (CLBP), with the Intracept Procedure – a novel, clinically proven and commercially available treatment designed to improve the quality of life for millions of indicated patients. For more information about Relievant Medsystems and the Intracept Procedure, visit www.relievant.com.
[1] Mirza SK, Deyo RA, Heagerty PJ, Turner JA, Martin BI, Comstock BA. One-year outcomes of surgical versus nonsurgical treatments for discogenic back pain: a community-based prospective cohort study. Spine J. 2013 Nov;13(11):1421-33. doi: 10.1016/j.spinee.2013.05.047. Epub 2013 Jul 23. PMID: 23890947; PMCID: PMC4699569.
[2] Herman PM, Broten N, Lavelle TA, Sorbero ME, Coulter ID. Health Care Costs and Opioid 28 Use Associated With High-impact Chronic Spinal Pain in the United States. Spine (Phila Pa 29 1976). 2019;44(16):1154-1161. doi:10.1097/BRS.0000000000003033.
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