Intracept® Procedure for Chronic Low Back Pain

Intracept® Procedure

What is Chronic Low Back Pain?

Low back pain impacts nearly 30% of the US population and leads to 52 million physician visits in the US annually. While the majority of people with low back pain improve, up to 15% develop chronic low back pain, which is back pain lasting more than 12 weeks.

Intracept® Procedure

Causes of Chronic Low Back Pain

While there are many causes of chronic low back pain, one cause is pain transmitted from the basivertebral nerve. The basivertebral nerve is found within the vertebrae. The branches of the basivertebral nerve extend to the upper and lower surfaces of the vertebrae. With age and degeneration of the spine, additional stress is placed on the vertebrae and can put pressure on the basivertebral nerve which can lead to chronic low back pain.

Key Benefits of Intracept®

  • 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 low back pain

See how Intracept® is revolutionizing the treatment of Chronic Low Back Pain

To find out if the Intracept® Procedure is right for you call us today.

Indications and Risks

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).

To learn more about the Intracept® Procedure and important safety information, please visit www.relievant.com

Intracept® Procedure Steps

Intracept® Procedure

1. Enter the vertebrae

Following a 3-5mm incision, an Introducer is advanced into the vertebrae

Intracept® Procedure

2. Create the channel

A curved instrument is utilized to create a channel to the trunk of the basivertebral nerve

Intracept® Procedure

3. Place the RF Probe

The Radiofrequency Probe is inserted into the curved path and placed at the trunk of the basivertebral nerve

Intracept® Procedure

4. Ablate the BVN

Radiofrequency energy (heat) is used to ablate the basivertebral nerve, rendering it unable to transmit pain signals

How Do I Know If the Intracept® Procedure Is Right for Me?

If you have experienced chronic low back pain for more than 6 months and have not received adequate relief through conservative care of at least 6 months, you may be a candidate. Your physician will help determine if the Intracept® Procedure may be right for you.

Intracept® Procedure

How Long Does It Take to Perform the Intracept® Procedure?

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.

Is There Clinical Evidence to Support the Intracept® Procedure?

Relievant Medsystems sponsored 3 clinical trials enrolling approximately 400 patients that demonstrated the safety and effectiveness of the Intracept® Procedure.

Frequently Asked Questions

What is the impact of 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
What is chronic low back pain?

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

How many people have chronic low back pain?

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

What causes chronic low back pain?

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.

What are the current treatment options for CLBP?

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.

Is there a treatment for vertebral endplate pain?

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.

What is the basivertebral nerve?

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.

What is the Intracept® Procedure?

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.

How long is the Intracept® Procedure?

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.

What is the recovery time?

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.

What evidence is available to support the Intracept® Procedure?

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

Is Intracept® FDA Cleared?

Yes, the Intracept® System received 510k Clearance.

Who is a candidate for the Intracept® Procedure?

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.

Is Intracept® the same as other nerve ablation procedures?

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.

How is Intracept® different from surgical options for chronic low back pain?

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.

See how Intracept® is revolutionizing the treatment of Chronic Low Back Pain

To find out if the Intracept® Procedure is right for you call us today.

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