The Intracept® Procedure
What is
Vertebrogenic Pain?
Vertebrogenic pain is a distinct type of chronic low back pain caused by damage to vertebral endplates, the tissue that covers the top and the bottom of each vertebral body and separates it from the disc. Disc degeneration, and the wear and tear that occurs with everyday living, produces stresses on the endplates that damage them, leading to inflammation and vertebrogenic pain. The basivertebral nerve (BVN), found within the vertebrae, carries pain signals from the inflamed endplates to the brain.
How is
Vertebrogenic Pain Treated?
The basivertebral nerve (BVN) enters the bone at the back of the vertebral body (the bones in your spine) and “branches” to the endplates (that are located at the top and the bottom of each vertebral body). When endplates are damaged, these nerve endings increase in number and “pick up” pain signals that are then sent to the brain through the BVN. The Intracept® Procedure relieves vertebrogenic pain by heating the basivertebral nerve (BVN) with a radiofrequency probe to stop it from sending pain signals to the brain.
How The
Intracept® Procedure Works
The Intracept Procedure is a minimally invasive, implant free procedure that preserves the overall structure of the spine. The Intracept Procedure is a same-day, outpatient procedure. Patients are under anesthesia, and the procedure generally lasts an hour. The procedure is FDA-cleared and is proven in multiple studies to be safe, effective, and durable. *2,3
the Pedicle
1. Access
Under fluoroscopic guidance, the Intracept Introducer Cannula is advanced through the pedicle
the Channel
2. Create
The Intracept Curved Cannula is utilized to create a channel to the trunk of the basivertebral nerve
the RF Probe
3. Place
The Intracept Radiofrequency Probe is inserted into the curved path and placed at the basivertebral nerve
the BVN
4. Ablate
The Relievant Radiofrequency Generator is utilized to ablate the basivertebral nerve
Main Benefits of
The Intracept® Procedure
Provides a treatment option for patients who have not responded to conservative therapy
Provides durable relief of chronic vertebrogenic low back pain
Minimally Invasive and Implant Free
Same day procedure; brief recovery
Preserves the structure of the spine
2 weeks to 3 months for most patients to feel relief
and Support
Safety
The Intracept Procedure is supported by unparalleled clinical evidence, including two Level I RCTs
Results from multiple clinical trials demonstrate the Intracept® Procedure is:
Safe
Strong safety profile with less than 0.3% 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.
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.
Who Can Benefit
from 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.
Clinical evidence demonstrates the majority of patients experience significant improvements in function and pain 3-months post procedure that are sustained more than 5 years after a single treatment. *2
How Do I Know If I’m a Candidate for Intracept®?
-
Chronic low back pain for at least six months,
-
Who have tried conservative care for at least six months, and
-
Whose MRI shows features consistent with Modic changes – indicating damage at the vertebral endplates has led to inflammation.
The Intracept Procedure, as with any procedure, has risks that should be discussed between the patient and medical provider.
Indicatons for Use: The Intracept 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).
[1] 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.
*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 Relievant data on file as of January 2023.