Relievant Medsystems, a company focused on transforming the diagnosis and treatment of vertebrogenic pain, a type of chronic low back pain (CLBP), today announced that the American Society of Pain & Neuroscience (ASPN) multidisciplinary work group of leading experts have assigned a Grade A evidence rating for basivertebral nerve (BVN) ablation and developed Best Practice Guidelines on the Diagnosis and Treatment of Vertebrogenic Pain with BVN ablation. The Best Practice Guidelines are now published in the Journal of Pain Research.
Following the publication of these guidelines, physicians can confidently recommend BVN ablation as the first treatment for patients presenting with anterior column pain and Modic changes* after failing six months of conservative care. Based on U.S. Preventive Services Task Force (USPSTF) definitions, an A Grade indicates high certainty that the net benefit is substantial in appropriately selected individuals.
“With strong clinical evidence including two level I randomized controlled trials and long-term data supporting the efficacy and safety of BVN ablation, this treatment option has taken an increasingly important role in the approach to treating chronic vertebrogenic low back pain in recent years,” said Professor Dawood Sayed M.D., lead author of the ASPN Best Practice Guidelines, anesthesiologist and Chief of Pain Medicine at The University of Kansas Health System. “The ASPN best practice guidelines are reflective of a marked shift in how we treat and provide life-changing, long-lasting improvement for patients with chronic vertebrogenic low back pain.”
For more information about ASPN’s BVN Best Practice Guidelines, register for a live webinar at 7:30 pm CT on Sept. 20 presented by publication authors.
Relievant Medsystems’ minimally invasive Intracept Procedure is the only FDA-cleared treatment for chronic vertebrogenic low back pain. The technology uses targeted radiofrequency energy to stop the basivertebral nerve from transmitting pain signals to the brain. The procedure typically takes place in an outpatient surgery center and lasts approximately one hour. Based on existing data, patients experience minimal post-procedure pain and generally quick recovery times. Patients often feel pain relief within two weeks of being treated with the Intracept Procedure.
“This is a historic day for the patients and physicians we serve to have published guidelines from a multidisciplinary society giving physicians a straightforward, actionable path forward to not only diagnose vertebrogenic pain but also integrate BVN ablation as the first treatment for patients who fit the criteria noted in the guidelines,” said Tyler Binney, President and CEO of Relievant Medsystems. “The Intracept Procedure has been life-changing for patients suffering from chronic vertebrogenic low back pain, and we’re thrilled that these guidelines will provide additional evidence-based support to physicians and ultimately expand patient access to this breakthrough technology.”
*Modic Type 1 and/or Modic Type 2 changes on MRI
Of the 30 million people in the U.S. with chronic low back pain, 1 in 6 are likely to have vertebrogenic pain, which is 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 becomes worse 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.