Just Clear, Rigorous,
High-Quality Data.

Results from Multiple Clinical Trials Demonstrate the Intracept Procedure is:

Safe

Strong safety profile with less than 0.3% rate of serious Intracept Procedure-related complications reported across nearly 400 clinical trial patients. 1

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

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

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

Mean VAS Over Time

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

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 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

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.

Society Guidelines
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
  1. Relievant data on file
  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