Chronic Vertebrogenic Low Back Pain
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).
Use of the Intracept Intraosseous Nerve Ablation System is contraindicated in:
- Patients with severe cardiac or pulmonary compromise.
- 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.
- Skeletally immature patients (generally < 18 years of age).
- Patients with implantable pulse generators (e.g., pacemakers, defibrillators) or other electronic implants.
- Situations where unintended tissue damage may result, based on the clinical assessment by the physician.
- Application with electrosurgical instruments NOT tested and specified for use with the Relievant RFG.
- As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure. To review the contraindications, warnings, and precautions click here.