Intracept™ Procedure safety

Address your pain with confidence

The Intracept Procedure has been proven to be safe.1 Take care of your pain with a minimally invasive procedure that does not alter your spine.

The Intracept Procedure is the first FDA-cleared treatment for vertebrogenic low back pain.

The Intracept Procedure is the most studied treatment 
for vertebrogenic 
pain with a strong safety profile.1

Proven safe: 
less than 0.3% rate 
of serious procedure-related complications reported.1

Well established and trusted—over 50,000 people have chosen it.

Frequently Asked Questions

Risks of the Intracept Procedure are very low but can include soreness, bruising, temporary numbness, infection, or nerve irritation at the treatment area.

Intracept is safer and less invasive than traditional surgeries like spinal fusion because it doesn't involve implants, cutting through muscles, or changing your spine's structure. Compared to ablation, Intracept targets specific nerves inside the bone rather than nerves outside the spine that commonly grow back.

Most patients feel better, but a few people might have temporary soreness or increased pain at the incision site for a short time after the procedure. Long-term pain worsening is rare.

If you have osteoporosis, talk to your doctor. Your doctor will evaluate your specific situation and determine whether or not you are a candidate for the Intracept Procedure.

Patients with active implantable pulse generators (such as pacemakers or defibrillators) may be candidates if the physician is able to safely deactivate the device for the procedure. Ask your doctor if you are a candidate.

Yes, you will still be able to feel pain if there's a new injury or problem in your low back. Intracept reduces chronic back pain, but it doesn’t remove your body's normal pain response.

Your doctor will evaluate your specific situation and existing hardware to confirm if it's safe and appropriate.

Patients have been studied up to 5 years after the Intracept Procedure and no new known side effects or complications related to the procedure have been found.2 There can be short-term radiating leg pain, depending on physician technique, but it resolves over time. Some doctors will prescribe a medication to help it resolve. There are no known long-term side effects.

Hear from Severyn

"It's just so hard to explain how every little thing is in your mind constantly wondering if it's going to be painful."

See more patient stories
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References

1. Data on file.

2. Fischgrund JS, Rhyne A, Macadaeg K, et al. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2020;29:1925–1934.

 

Important Safety Information

Indications for use: The Intracept™ Intraosseous Nerve Ablation System is indicated for patients who have had chronic low back pain for at least six months, who have tried conservative care for at least six months, and whose MRI shows features consistent with Modic changes – indicating damage at the vertebral endplates has led to inflammation. Not every patient who meets these criteria is a candidate for the Intracept Procedure, however – in fact, there are specific characteristics indicating a patient should not be considered for the procedure.

Contraindications: Patients who are pregnant. Patients with weakened cardiac or pulmonary function, having an active implanted electronic medical device in the body (such as a pacemaker or defibrillator), being diagnosed with a systemic or local infection, or having an anatomy that could be damaged unintentionally while ablating the basivertebral nerve (based on your physicians’ clinical review). Patients who are skeletally immature – which generally means individuals under the age of 18 are not candidates.

Warnings: There are also certain risks and precautions regarding the procedure which you should be aware of before proceeding. With all medical procedures, there are risks and precautions associated with the procedure and the use of the device, talk with your doctor about what indicates, and contraindicates, certain patients for the Intracept Intraosseous Nerve Ablation System. For complete indications for use, contraindications, warnings, precautions, and side effects visit www.relievant.com/intracept/.

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.