Just Clear, Rigorous,
High-Quality Data.

Results from Multiple Clinical Trials Demonstrate the Intracept™ Procedure is:

Safe

Strong safety profile with less than 0.2% rate of serious device or procedure-related complications reported.

Effective

Two Level I RCTs demonstrate that the Intracept Procedure is an effective treatment compared to both a sham-control procedure and to non-surgical standard care.2,3

Durable

Significant improvements in function and pain seen at 3 months post the Intracept Procedure are sustained more than 5 years after a single treatment.2

Reproducible

Consistency across clinical studies with results reproduced in a typical community spine practice.2-6
BVN Ablation Treatment

SMART Trial

5-Year Durability2

  • VAS: 4.38 reduction at 5 years (from 6.74 to 2.35 (p<0.001))†
  • ODI: 25.95 reduction at 5 years (from 42.81 to 16.86 (p<0.001))†
  • One-third (34%) of patients were pain free at 5 years†

†p-value from paired t-tests for BVN ablation arm patients with a 5-year visit

Read the Paper
Mean VAS Over Time

INTRACEPT Study

24-Month Results Demonstrate
Sustained Relief 3

  • VAS: 4.1 cm mean reduction from baseline to 24 months post-procedure (p<0.001)†
  • ODI: 28.5 point mean reduction from baseline to 24 months (p<0.001)†
  • 31% of patients were pain-free 24 months after BVN ablation treatment†

†p-values from paired t-tests of BVN ablation arm patients with a 24-month visit

Read the Paper
Mean VAS Baseline 24 months

Prospective, Single-Arm Cohort Study

Sustained Relief at 12 Months in
Typical Spine Practices6

  • VAS: Mean reduction of 4.3 (p<0.001) from a baseline of 6.82†
  • ODI: Mean improvement of 32.31 (p<0.001) from a baseline of 46.98†
  • 69% of patients reported >50% reduction in pain while 38% reported being pain-free†

†p-values from paired t-tests of BVN ablation treated patients with a 12-month visit

Read the Paper
Mean VAS Over Time

Pooled Three-Year Outcomes from Two Prospective Clinical Trials

Demonstrate Long-Term Pain Relief and Reduced Opioid Use11

  • Statistically significant (p<0.0001) improvements of 31.2 points and 4.3 points were observed compared to baseline, for mean ODI and mean NPS, respectively.
  • 74% fewer patients were actively using opioid medications for low back pain and 84% fewer patients required spinal injections for the same pain source and treatment level at three years following treatment.
  • 26.3% of patients reported being 100% pain-free
Read the Paper

Pilot Clinical Study

Efficacy of BVN Ablation
in a Clinical Setting 7

  • Ablation of the BVN for the treatment of chronic lumbar back pain significantly improved patients’ self-reported outcome early in the follow-up period
  • Improvements in function persisted throughout the 1-year study period
  • ODI: Statistically significant mean baseline reduction from 52±13 to 23±21 at 3 months follow-up (p<.001); maintained through 12-month follow-up
Read the Paper

Looking for More Proof?

Clinical Trials

Becker S, Hadjipavlou A, Heggeness M, Ablation of the basivertebral nerve for treatment of back pain: a clinical study. The Spine Journal: Official Journal of the North American Spine Society 2017; 17: 218–223

Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2018;27(5):1146-56. doi:10.1007/s00586-018-5496-1

Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 2-year results from a prospective randomized double-blind sham-controlled multicenter study. Int J Spine Surg. 2019;13(2):110-9. doi:10.14444/6015

Fischgrund J, Rhyne A, Macadaeg K, et al. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2020;29(8):1925-34. doi.org/10.1007/s00586-020-06448-x

Khalil J. Pooled Intraosseous Basivertebral Nerve Ablation: 4-Year Effectiveness and Safety Results from Two Long-Term Follow-up Studies. Lecture ASPN annual meeting; July 13-16, 2023. Miami, FL.

Khalil JG, Smuck M, Koreckij T, et al. A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Spine J. 2019;19(10):1620-32. doi:10.1016/j.spinee.2019.05.598

Koreckij T, Kreiner S, Khalil JG, Smuck M, Markman J, Garfin S. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the
treatment of chronic low back pain: 24-month treatment arm results. NASSJ. Published online October 26, 2021. DOI: https://doi.org/10.1016/j.xnsj.2021.100089

Macadaeg K, Truumees E, Boody B, Pena E, Arbuckle A., Gentile, J, et al. A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results. NASSJ 2020;3(100030). E-pub 18 Sept 2020. https://doi.org/10.1016/j.xnsj.2020.100030

Markman JD, Rhyne A, Sasso R, et al. Association between opioid use and patient-reported outcomes in a randomized trial evaluating basivertebral nerve ablation for the relief of chronic low back pain. Neurosurgery: March 2020 – Volume 86 – Issue 3 – p 343-347 doi: 10.1093/neuros/nyz093

Smuck M, Khalil JG, Barrett K, Hirsch JA, Kreiner S, Koreckij T, et al. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results. Reg Anesth Pain Med. 2021;0:1-5. doi:10.1136/rapm-2020-102259

Smuck M, Truumees E, Macadaeg K, Jaini AM, Chatterjee S, Levin J. Intraosseous basivertebral nerve ablation: pooled long-term outcomes from two prospective clinical trials. Interventional Pain Medicine. 2023; 2(2). https://doi.org/10.1016/j.inpm.2023.100256.

Truumees E, Macadaeg K, Pena E, Arbuckle A, Gentile, J, Funk R, et al. A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. ESJ 2019;28:1594-1602. https://doi.org/10.1007/s00586-019-05995-2

Systematic Reviews/Literature Reviews

Urits I, Noor N, Johal AS, Leider J, Brinkman J, Fackler N, Vij N, An D, Cornett EM, Kaye AD, Viswanath O. Basivertebral Nerve Ablation for the Treatment of Vertebrogenic Pain. Pain Ther. 2021 Jun;10(1):39-53. doi: 10.1007/s40122-020-00211-2. Epub 2020 Oct 31. PMID: 33128702; PMCID: PMC8119576.

Conger A, Schuster NM, Cheng DS, Sperry BP, Joshi AB, Haring RS, Duszynski B, McCormick ZL. The Effectiveness of Intraosseous Basivertebral Nerve Radiofrequency Neurotomy for the Treatment of Chronic Low Back Pain in Patients with Modic Changes: A Systematic Review. Pain Med. 2021 May 21;22(5):1039-1054. doi: 10.1093/pm/pnab040. PMID: 33544851.

Tieppo Francio V., Sherwood D., Twohey E., Barndt B., Pagan-Rasodo R., Eubanks J., Sayed D. Developments in Minimally Invasive Surgical Options for Vertebral Pain: Basivertebral Nerve Ablation – A Narrative Review. JPR. 2021;14:1887=1907

Michalik A, Conger A, Smuck M, Maus TP, McCormick ZL. Intraosseous Basivertebral Nerve Radiofrequency Ablation for the Treatment of Vertebral Body Endplate Low Back Pain: Current Evidence and Future Directions. Pain Med. 2021 Jul 25;22(Suppl 1):S24-S30. doi: 10.1093/pm/pnab117. PMID: 34308955.

Conger A, Burnham TR, Clark T, Teramoto M, McCormick, ZL. The Effectiveness of Intraosseous Basivertebral Nerve Radiofrequency Ablation for the Treatment of Vertebrogenic Low Back Pain: An Updated Systematic Review with Single-Arm Meta-analysis, Pain Medicine, Volume 23, Issue Supplement_2, August 2022, Pages S50–S62, https://doi.org/10.1093/pm/pnac070

Schnapp W, Martiatu K, Delcroix G. Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: A Scoping Review of the Literature. Pain Physician. 2022:E551-E562. Free Access.

Society Guidelines

Sayed D, Grider J, Strand N, et al. The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain [published correction appears in J Pain Res. 2022 Dec 24;15:4075-4076]. J Pain Res. 2022;15:3729-3832. Published 2022 Dec 6. doi:10.2147/JPR.S386879.

Sayed D, Naidu RK, Patel KV, et al. Best practice guidelines on the diagnosis and treatment of vertebrogenic pain with basivertebral nerve ablation from the American Society of Pain and Neuroscience. J Pain Res. 2022;15:2801-2819
https://doi.org/10.2147/JPR.S378544

Lorio M., Clerk-Lamalice O., Beall D., Julien T., International Society for the Advancement of Spine Surgery Guideline—Intraosseous Ablation of the Basivertebral Nerve for the Relief of Chronic Low Back Pain. IJSS 2020;14(1):18-25.  https://doi.org/10.14444/7002

Independent Clinical Analysis

Boody B, Sperry BP, Harper K, Macadaeg K, McCormick ZL, The Relationship Between Patient Demographic and Clinical Characteristics and Successful Treatment Outcomes After Basivertebral Nerve Radiofrequency Ablation: A Pooled Cohort Study of Three Prospective Clinical Trials, Pain Medicine, Volume 23, Issue Supplement_2, August 2022, Pages S2–S13, https://doi.org/10.1093/pm/pnac050

McCormick Z, Sperry BP, Boody BS, et al. Pain Location and Exacerbating Activities Associated with Treatment Success Following Basivertebral Nerve Ablation: An Aggregated Cohort Study of Multicenter Prospective Clinical Trial Data, Pain Medicine, Volume 23, Issue Supplement_2, August 2022, Pages S14–S33, https://doi.org/10.1093/pm/pnac069

McCormick ZL, Conger A, Smuck M, et al. Magnetic Resonance Imaging Characteristics Associated with Treatment Success from Basivertebral Nerve Ablation: An Aggregated Cohort Study of Multicenter Prospective Clinical Trials Data, Pain Medicine, Volume 23, Issue Supplement_2, August 2022, Pages S34–S49, https://doi.org/10.1093/pm/pnac093

Conger A, Smuck M, Truumees E, Lotz JC, et al. Vertebrogenic Pain: A Paradigm Shift in Diagnosis and Treatment of Axial Low Back Pain, Pain Medicine, Volume 23, Issue Supplement_2, August 2022, Pages S63–S71, https://doi.org/10.1093/pm/pnac081

Healthcare Economics

Kreiner S, Reiter MF, Bydon M, Schneider BJ, et al. Basivertebral Nerve Ablation, Defining Appropriate Coverage Positions. North American Spine Society. Published February 2023. ISBN 978-1-929988-77-X

McCormick Z, Curtis T, Cooper A, Wheatley M, Smuck M. Low Back Pain-related Healthcare Utilization following Intraosseous Basivertebral Nerve Radiofrequency Ablation: A Pooled Analysis from Three Prospective Clinical Trials, Pain Medicine, 2023;, pnad114, https://doi.org/10.1093/pm/pnad114

  1. Relievant data on file as of Q2 2023
  2. Fischgrund J, Rhyne A, Macadaeg K, et al. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2020;29(8):1925-34. doi.org/10.1007/s00586-020-06448-x
  3. Koreckij T, Kreiner S, Khalil JG, Smuck M, Markman J, Garfin S. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the
    treatment of chronic low back pain: 24-month treatment arm results. NASSJ. Published online October 26, 2021. DOI: https://doi.org/10.1016/j.xnsj.2021.100089
  4. Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2018;27(5):1146-56. doi:10.1007/s00586-018-5496
  5. Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 2-year results from a prospective randomized double-blind sham-controlled multicenter study. Int J Spine Surg. 2019;13(2):110-9. doi:10.14444/6015
  6. K. Macadaeg, E. Truumees, B. Boody, E. Pena, J. Arbuckle II, J. Gentile, R. Funk, D. Singh, S. Vinayek, A prospective, single arm study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results, North American Spine Society Journal (NASSJ) (2020), doi.org/10.1016/j.xnsj.2020.100030
  7. Becker S, Hadjipavlou A, Heggeness M, Ablation of the basivertebral nerve for treatment of back pain: a clinical study. The Spine Journal: Official Journal of the North American Spine Society 2017; 17: 218–223
  8. Fischgrund JS, Rhyne A, Franke J, Sasso R, Kitchel S, Bae H, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: two-year results from a prospective randomized double-blind sham-controlled multi-center. Study. Int J Spine Surg 2019;13(2).
  9. Khalil J, Smuck M, Koreckij T, Keel J, Beall D, Goodman B, Kalapos P, Nguyen D, Garfin S. A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain. Spine J. 2019 Jun 20. pii: S1529-9430(19)30800-9. doi: 10.1016/j.spinee.2019.05.598.
  10. Smuck M, Khalil JG, Barrett K, Hirsch JA, Kreiner S, Koreckij T, et al. A prospective, randomized, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results.  Reg Anesth Pain Med. 2021;rapm-2020-102259. doi:10.1136/rapm-2020-102259

  11. Smuck M, Truumees E, Macadaeg K, Jaini AM, Chatterjee S, Levin J. Intraosseous basivertebral nerve ablation: pooled long-term outcomes from two prospective clinical trials. Interventional Pain Medicine. 2023; 2(2). https://doi.org/10.1016/j.inpm.2023.100256.

  12. Khalil J. Pooled Intraosseous Basivertebral Nerve Ablation: 4-Year Effectiveness and Safety Results from Two Long-Term Follow-up Studies. Lecture ASPN annual meeting; July 13-16, 2023. Miami, FL.