Minimally Invasive Intracept® Procedure

Candidates for the Intracept® Procedure

Patients who suffer from chronic vertebrogenic low back pain (CLBP), many of whom may have previously been diagnosed with discogenic low back pain, could be ideal candidates for the Intacept® Procedure. The indicated patient has chronic low back pain of at least six months duration, has not responded to at least six months of conservative care, and presents with degenerative endplate changes consistent with Type 1 or Type 2 Modic changes at L3 through S1 on an MRI.

Research over the past 30 years has concluded that vertebral body endplates are a significant source of chronic low back pain and that the basivertebral nerve (BVN) – located within the vertebral body - transmits pain from damaged and degenerated vertebral endplates. Intracept® stops the basivertebral nerve from transmitting these signals.

What is the Intracept® Procedure?

The Intracept® Procedure is a minimally invasive treatment that stops pain signals from the Basivertebral Nerve using radiofrequency energy (heat). The procedure can be performed within the same day, implant-free, preserving future treatment options. It is performed through two small one-centimeter incisions per every two vertebrae.

During the procedure, the surgeon advances a specialized introducer into the pedicle of the vertebrae to create a channel. A curved probe instrument is passed through the introducer and placed at the base of the Basivertebral Nerve. The instrument uses radiofrequency energy to ablate the nerve, rendering it unable to transmit pain signals.

Results of the Intracept® Procedure

According to multiple high-quality clinical studies, including two level-one randomized controlled trials and five-year outcomes data, key findings include an improvement of more than 20 points in mean Oswestry Disability Index (ODI) and more than two centimeters reduction in mean Visual Analogue Scale (VAS) at three months. The improvements in pain and function are durable, lasting more than five years post-procedure.

A significant decrease in the number of patients using opioids or injections long-term has been reported. Nearly 80% of patients who have undergone the Intracept® Procedure indicated that they would undergo the procedure again for the same condition.

What are the risks of the Intracept® Procedure?

Failure of the Intracept® System could result in an unintended increase of output power to the Probe. The Probe may interfere and adversely influence the operation of other electronic equipment. The system should not be used on patients with implantable pulse generators or other electronic device implants. Doing so could lead to electromagnetic interference and possible death. Minor neuromuscular stimulation is possible when arcs between ACTIVE ELECTRODE and tissue occur. The system has been designed to minimize the possibility of neuromuscular stimulation. The use of damaged equipment may cause patient injury.

To learn more about the Intracept® Procedure, visit www.relievant.com/intracept-procedure