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The only procedure designed to relieve vertebrogenic pain
The Intracept Procedure is a minimally invasive procedure designed to target the basivertebral nerve (BVN) for the relief of chronic vertebrogenic low back pain. Vertebrogenic pain is a distinct type of chronic low back pain caused by damage to vertebral endplates, the interface between the disc and the vertebral body.
This proven procedure is supported by strong scientific evidence, including two Level I RCTs that demonstrate durable improvements in both pain and function after a single treatment.1,2
How the Intracept Procedure works
The BVN enters through an opening in the back of the vertebral body and branches near the center of the vertebral body, sending nerves to innervate the superior and inferior endplates. These nerve endings transmit pain signals from the endplate to the brain and have been shown to increase in number with endplate damage or degeneration.3-5 The Intracept Procedure ablates the BVN to stop it from sending pain signals.
For more information on how to bring the Intracept Procedure to your practice, contact us.
If you are a patient looking for pain relief, see if you may benefit from the procedure by connecting with an Intracept-trained physician near you.
The Intracept Procedure is supported by unparalleled clinical evidence, including two Level I RCTs
Results from multiple clinical trials demonstrate the Intracept Procedure is:
Identify appropriate candidates for the Intracept Procedure
Patients who find relief from the Intracept Procedure often describe pain in the middle of their low back that is made worse by physical activity, prolonged sitting, and bending forward, or with bending and lifting.6
Bending
Lifting
Activity
Sitting
To confirm that a patient has vertebrogenic pain, use MRI to look for specific changes that occur with endplate inflammation, which are called Modic changes.
Learn about key reimbursement and coverage information for the Intracept Procedure
- Established ICD-10-CM code for vertebrogenic low back pain (M54.51) and two Category I CPT codes for BVN ablation (64628 and 64629)
- Continued coverage expansion, including recent commercial coverage policies from Anthem BCBS, Cigna and Humana as well as Medicare local coverage determinations from Palmetto GBA and Noridian
Relievant Medsystems is now part of Boston Scientific
*Data on file.
- 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
- 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: https://doi.org/10.1016/j.xnsj.2020.100030
- Fras C, Kravetz P, Mody DR, Heggeness MH. Substance P-containing nerves within the human vertebral body: an immunohistochemical study of the basivertebral nerve. The Spine Journal: Official Journal of the North American Spine Society. 2003;3(1):63-7.
- Bailey JF, Liebenberg E, Degmetich S, Lotz JC. Innervation patterns of PGP 9.5-positive nerve fibers within the human lumbar vertebra. Journal of Anatomy 2011;218(3):263-70.
- Lotz JC, Fields AJ, Liebenberg EC. The Role of the Vertebral End Plate in Low Back Pain. Global Spine J 2013;03:153-64.
- 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
Results from clinical studies are not predictive of results in other studies. Results in other studies may vary.
Indications for Use: The Intracept™ Procedure Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change). Contraindications - Use of the Intracept Intraosseous Nerve Ablation System is contraindicated in: Patients with severe cardiac or pulmonary compromise, patients with active implantable pulse generators (e.g. pacemakers, defibrillators), patients where the targeted ablation zone is < 10 mm away from a sensitive structure not intended to be ablated, including the vertebral foramen (spinal canal), patients with active systemic infection or local infection in the area to be treated, patients who are pregnant, and/or skeletally immature patients (generally ≤ 18 years of age). Refer to the Instructions for Use provided with the Intracept Procedure or www.relievant.com/intracept/ for potential adverse effects, warnings, and precautions prior to using this product.
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.