The Intracept Procedure is a minimally invasive procedure that targets the basivertebral nerve for the relief of 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).
- Provides a treatment option for patients who have not responded to conservative therapy
- Minimally invasive, outpatient procedure
- Implant-free and preserves the structure of the spine
- Provides durable relief of chronic vertebrogenic low back pain
During the days before surgery, a doctor may recommend that you avoid taking drugs that make it hard for blood to clot, such as aspirin and warfarin. On the day of surgery, you will be told not to eat or drink anything for several hours before the procedure. You can take any medication a doctor approves, along with sips of water.
A surgeon will perform intracept procedure in a hospital. You may have either local or general anesthetic. The surgical procedure is as follows:
- Access the pedicle: Under fluoroscopic guidance, the Intracept Introducer Cannula is advanced through the pedicle
- Create the channel: The Intracept Curved Cannula is utilized to create a channel to the trunk of the basivertebral nerve
- Place the RF Probe: The Intracept Radiofrequency Probe is inserted into the curved path and placed at the basivertebral nerve
- Ablate the BVN: The Relievant Radiofrequency Generator is utilized to ablate the basivertebral nerve
You will be able to go home from the hospital the same day. You should not drive unless a medical professional approves it.
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Risks and complications
Risks and complications of intracept procedure may include:
- Increased back pain
- Nerve damage
Although risks related to intracept are rare, serious complications can occur.
Contraindications and Risks
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
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