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Illustration of spinal vertebra showing probe applying energy to basivertebral nerve. intracept-clinical-education-hero.jpg

The Intracept™ System: Clinical evidence

Just clear, rigorous, high-quality data.

Results from multiple clinical trials demonstrate the Intracept Procedure is:

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Safe

Strong safety profile with less than 0.3% rate of serious device or procedure-related complications reported.1

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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

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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

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Reproducible

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

BVN ablation treatment in multiple studies: Mean visual analog scale (VAS) over time 2, 3, 6-9

Line chart comparing VAS scores across four studies showing similar long-term improvement trends.

*SMART RCT US per protocol treatment arm at mean of 6.4 years
** Standard arm re-baselined and offered active treatment of a median of 5.8 months

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

Graph showing VAS score decline from 6.7 at baseline to 2.35 after five years.

*n=Global PP  **n=US PP
*p-value from paired t-tests for BVN ablation arm patients with a 5-year visit

INTRACEPT study

24-month results demonstrate sustained relief3

  • 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 to 24 months

Line chart comparing mean VAS scores across treatment and control groups through 24 months.

*p-value from a t-test on the basivertebral nerve ablation treatment arm with a 24-month visit.
**Multiple imputations for 3 Month ODI missing values. All other measurements as observed, no imputations for missing data.

Prospective, single-rm 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
(Baseline to 12 months, p<0.001)

Chart showing mean VAS score decrease from 6.8 at baseline to 2.3 at 12 months and 2.5 at 24 months.

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

5-Year pooled analysis from three prospective clinical trials

Demonstrate clinically and statistically significant improvement in both pain and function8

  • 83% of patients reported a ≥ 2-point reduction in VAS from baseline (p<0.0001)
  • 78% of patients had a ≥ 15-point reduction in ODI from baseline (p<0.0001)
  • Nearly 66% of patients had a 50% or more reduction in pain relief (p<0.0001)
  • Nearly 33% of patients reported being 100% pain free after 5 years (p<0.0001)
Read the paper

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?

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., et al. Intraosseous basivertebral nerve ablation: 5-year outcomes from three long-term follow-up studies.
Interventional Pain Medicine, Volume 3, Issue 4, 2024,100529, ISSN 2772-5944, https://doi.org/10.1016/jinpm.2024.100529

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 thetreatment of chronic low back pain: 24-month treatment arm results. NASS). 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. NASS) 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

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. 2022;23(Suppl_2):S50-S62. https://doi.org/10.1093/pm/pnac070

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 Medicine. 2021;22(5):1039-1054. https://doi.org/10.1093/pm/pnab040

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 Medicine. 2021;22(Supp|_1):524-530. https://doi.org/10.1093/pm/pnab117

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.

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. J Pain Res.
2021;14:1887-1907.

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;10(1):39-53. https://doi.org/10.1007/s40122-020-00211-2

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. Int J Spine Surg. 2020;14(1):18-25. https://doi.org/10.14444/7002

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. J Pain Res. 2022;15:3729-3832.
https://doi.org/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

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. 2022;23(Suppl_2):S2–S13. https://doi.org/10.1093/pm/pnac050

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. 2022;23(Suppl_2):S63–S71. https://doi.org/10.1093/pm/pnac081

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. 2022;23(Suppl_2):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. 2022;23(Suppl_2):S34–S49. https://doi.org/10.1093/pm/pnac093

Schnapp W, Schnapp M, Gottlieb J, Alexandre LC, Martiatu K, Delcroix G. Prospective Cohort Study of Basivertebral Nerve Ablation for Chronic Low Back Pain in a Real-World Setting: 12-Month Follow-Up. Interventional Pain Medicine. 2024;3(4):100446. https://doi.org/10.1016/j.inpm.2024.100446

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

Smuck M, McCormick ZL, Gilligan C, et al. A Cost-Effectiveness Analysis of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain. The Spine Journal. Published online September 25, 2024. https://doi.org/10.1016/j.spinee.2024.09.016

View Boston Scientific Intracept Intraosseous Nerve Ablation System indications, safety, and warnings

  1. 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 G, Smuck M, Markman), GarfinS. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the
    treatment of chronic low back pain: 24-month treatment arm results. NASS]. 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 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 (NASS]) (2020), doi.org/10.1016/j.xnsj.2020.1
  7. Smuck M, Khalil JG, Barrett K, Hirsch JA, Kreiner S, KoreckiT, 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
  8. Khalil, J., et al. Intraosseous basivertebral nerve ablation: 5-year outcomes from three long-term follow-up studies. Interventional Pain Medicine, Volume 3, Issue 4, 2024,100529, ISSN 2772-5944, https://doi.org/10.1016/j.inpm.2024.100529.
  9. Smuck M, Truumees E, Macadaeg K, Jaini AM, Chatterjee S, Levin J. Intraosseous basivertebral nerve ablation: pooled longterm outcomes from two prospective clinical trials. Interventional Pain Medicine. 2023; 2(2).
    https://doi.org/10.1016/j.inpm.2023.100256.
  10. 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