Intracept® Procedure for Chronic Low Back Pain

• Low back pain is the most expensive occupational disorder in the United States
• Leading cause of disability worldwide
• 30% of Americans have low back pain at any given time
• Leads to approximately 52 million physician visits in the United States annually
• Opioids are the most common class of analgesic medication prescribed for low back pain
• Those with chronic low back pain use significantly more opioids per individual than individuals with other primary non-cancer diagnoses
• 31% of low back pain individuals were prescribed opioids within the first 6 months of initial diagnosis, which increased to 42.1% within three years

Chronic low back pain is defined as low back pain that lasts for 12 weeks or more.

Approximately 30 million people in the United States are currently living with chronic low back pain, with nearly 900,000 new occurrences each year.

There are many causes of chronic low back pain, including:

• Vertebral body endplates (vertebrogenic pain)
• Degenerative disc disease(discogenic pain)
• Muscle or ligament strain
• Herniated disc
• Facet joint dysfunction
• Sacroiliac joint dysfunction
• Spinal Stenosis
• Spondylolisthesis
• Osteoarthritis
• Deformity
• Trauma
• Compression Fracture

There are other causes of chronic low back pain not included in the above list. Healthcare providers diagnose the cause(s) of individual’s pain based on medical history, physical examination, and diagnostic tests.

Patients typically begin treatment with conservative therapy, which can include:

• Medications(over-the-counter, prescribed non-opioid, opioid)
• Physical therapy, massage therapy
• Chiropractic care
• Injections
• Transcutaneous electrical nerve stimulation (TENS)

If conservative therapy does not provide adequate pain relief, surgery might be an option. Surgical options can include:

• Spinal fusion
• Total disc replacement

While both non-surgical (conservative therapy) and surgical options are available for patients suffering from chronic low back pain, the majority of people do not get adequate relief with conservative therapy and are not candidates for spine surgery.

To date, there has not been a non-surgical or surgical treatment focused on the vertebral endplates. The Intracept® Procedure is a new, minimally invasive procedure that targets the basivertebral nerve for the relief of chronic low back pain.

The basivertebral nerve is a nerve found within the bones of the spine, called vertebrae. The basivertebral nerve enters the vertebrae posteriorly and sends nerve branches to the vertebral endplates. Two decades of scientific and clinical research have demonstrated the basivertebral nerve transmits chronic low back pain signals from the vertebral endplates.

Intracept® is a minimally invasive procedure that targets the basivertebral nerve for the relief of chronic low back pain. Intracept® is an outpatient procedure, which does not involve an implant or change the structure of the spine. Clinical studies have demonstrated nearly immediate relief of patient’s back pain and long-lasting relief.

Access instruments are guided through a small incision (3-5mm) to reach the basivertebral nerve. Radiofrequency energy, or heat, then ablates the basivertebral nerve to stop the transmission of pain signals.

Procedure times vary depending on the number of vertebrae to be treated and the specific patient. The average time of the Intracept® procedures performed have been approximately 1 hour and 20 minutes.

Each patient along with their physician determine appropriate recovery time and activities. Most patients that have undergone the Intracept® Procedure have been able to resume regular activities within a week or two after the procedure.

Relievant Medsystems developed the Intracept® Procedure and sponsored a 225-patient clinical trial that demonstrated the safety and effectiveness of the Intracept® Procedure.

Yes, the Intracept® System received 510k Clearance.

The indicated patient for the Intracept® Procedure is one with 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 either Type 1 or Type 2 Modic changes at L3 through S1 on an MRI. Physicians will help determine if the Intracept® Procedure is appropriate.

While the Intracept® Procedure targets a nerve in the spine and uses radiofrequency energy, or heat, to ablate the nerve, the Intracept® Procedure targets the basivertebral nerve within the vertebrae and ablates the basivertebral nerve for the relief of chronic low back pain. Other ablation procedures currently performed for chronic low back pain do not target or ablate the basivertebral nerve, and have not demonstrated long-lasting pain relief.

Unlike spinal fusion, total disc replacement, and spinal cord stimulation, the Intracept® Procedure is implant-free and preserves the natural structure of the spine. Average recovery times following the Intracept® Procedure are less than reported for spinal fusion and total disc replacement.