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The Intracept™ Procedure:

Lasting relief from vertebrogenic  chronic low  back pain

What is vertebrogenic chronic low back pain?

Vertebrogenic low back pain is caused by damage to parts of your spine called vertebral endplates. The damage can develop over time with the wear and tear on your back that comes from everyday activities.

Vertebrogenic pain is usually felt in the middle of the low back and is often made worse by:1

Physical activity

Prolonged sitting

Bending forward

Lifting objects

How does the Intracept Procedure work?

The Intracept Procedure is a safe, minimally invasive procedure that is proven to provide durable vertebrogenic pain relief.2

The Intracept Procedure works by targeting the basivertebral nerve, which is the nerve that sends pain signals from damaged endplates.

During the procedure, the doctor introduces a small probe near the trunk of the basivertebral nerve, delivering radiofrequency energy to heat the nerve and stop it from sending pain signals to the brain.

Patient recovery time tends to be quick, and most people start to feel pain relief from within two weeks up to three months.2-4

How can I find out more?

Find a doctor

Connect with an Intracept-trained physician near you.

References:

1. Koreckij T, Kreiner S, Khalil JG, Smuck M, Markman J, Garfin S. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-month treatment arm results. NASSJ. Published online October 26, 2021. DOI: https://doi.org/10.1016/j.xnsj.2021.100089

2. Fischgrund J, 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(8):1925-34. http://doi.org/10.1007/s00586-020-06448-x

3. K. Macadaeg, E. Truumees, B. Boody, E. Pena, J. Arbuckle II, J. Gentile, R. Funk, D. Singh, S. Vinayek, A prospective, single arm study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results, North American Spine Society Journal (NASSJ) (2020), doi.org/10.1016/j.xnsj.2020.100030

4. Smuck M, Khalil JG, Barrett K, Hirsch JA, Kreiner S, Koreckij T, et al. A prospective, randomized, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results. Reg Anesth Pain Med. 2021;rapm-2020-102259. doi:10.1136/rapm-2020-102259. Open access. Results from clinical studies are not predictive of results in other studies.

Results in other studies may vary.

Indications for Use: The Intracept™ Procedure 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 include being pregnant, having 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). The Intracept Procedure is also contraindicated in patients who are skeletally immature – which generally means individuals under the age of 18 are not candidates. There are also certain risks and precautions regarding the procedure which you should be aware of before proceeding. Talk with your doctor about what indicates, and contraindicates, certain patients for the Intracept Procedure – as well as the risks and precautions for the procedure. 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.

Indications for Use: The Boston Scientific Spinal Cord Stimulator Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain, Diabetic Peripheral Neuropathy of the lower extremities, radicular pain syndrome, radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, epidural fibrosis, degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions), arachnoiditis, multiple back surgeries. The Boston Scientific Spectra WaveWriter™, WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems are also indicated as an aid in the management of chronic intractable unilateral or bilateral low back and leg pain without prior back surgery.

Contraindications. The Spinal Cord Stimulator systems are not for patients who are unable to operate the system, have failed trial stimulation by failing to receive effective pain relief, are poor surgical candidates, or are pregnant.

MR Conditional symbol

Boston Scientific’s ImageReady™ MRI Technology makes safe MRI head scans possible. Patients implanted with the Precision Spectra™ or Spectra WaveWriter™ Spinal Cord Stimulator Systems with ImageReady™ MRI Technology are "MR Conditional" only when exposed to the MRI environment under the specific conditions defined in the applicable ImageReady™ MRI Head Only Guidelines for Precision Spectra™ or Spectra WaveWriter™ Spinal Cord Stimulator Systems.

MR Conditional symbolBoston Scientific’s ImageReady™ MRI Full Body Technology makes safe MRI scans possible. The Precision Montage™ MRI, WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems with ImageReady™ MRI Full Body Technology are “MR Conditional” only when exposed to the MRI environment under the specific conditions defined in the applicable ImageReady™ MRI Full Body Guidelines for Precision Montage™ MRI or WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems.

Warnings. Patients implanted with Boston Scientific Spinal Cord Stimulator Systems without ImageReady™ MRI Technology should not be exposed to Magnetic Resonance Imaging (MRI). Exposure to MRI may result in dislodgement of the stimulator or leads, heating of the stimulator, severe damage to the stimulator electronics and an uncomfortable or jolting sensation. As a Spinal Cord Stimulation patient, you should not have diathermy as either a treatment for a medical condition or as part of a surgical procedure. Strong electromagnetic fields, such as power generators or theft detection systems, can potentially turn the stimulator off, or cause uncomfortable jolting stimulation. The system should not be charged while sleeping. The Spinal Cord Stimulator system may interfere with the operation of implanted sensing stimulators such as pacemakers or implanted cardiac defibrillators. Advise your physician that you have a Spinal Cord Stimulator before going through with other implantable device therapies so that medical decisions can be made and appropriate safety measures taken. Patients using therapy that generates paresthesia should not operate motorized vehicles such as automobiles or potentially dangerous machinery and equipment with the stimulation on. Stimulation must be turned off first in such cases. For therapy that does not generate paresthesia (i.e. subperception therapy) it is less likely that sudden stimulation changes resulting in distraction could occur while having stimulation on when operating moving vehicles, machinery, and equipment. Your doctor may be able to provide additional information on the Boston Scientific Spinal Cord Stimulator systems.  For complete indications for use, contraindications, warnings, precautions, and side effects, call 866.360.4747 or visit Pain.com. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

Indications for Use: The Superion™ Indirect Decompression System (IDS) is indicated to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate degenerative lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, having radiographic evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion™ Interspinous Spacer is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, with or without back pain, who have undergone at least 6 months of non-operative treatment. The Superion Interspinous Spacer may be implanted at one or two adjacent lumbar levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5. Contraindications, warnings, precautions, side effects. The Superion Indirect Decompression System (IDS) is contraindicated for patients who: have spinal anatomy that prevent implantation of the device or cause the device to be unstable in situ (i.e., degenerative spondylolisthesis greater than grade 1), Cauda equina syndrome, or prior decompression or fusion at the index level, scoliosis or spinous process fractures, osteoporosis, infection, allergy or reaction to any metal or implant or a high Body Mass Index. Avoid strenuous activity for 6 weeks after surgery, contact your physician if there is fluid leaking from your incision, if you have pain, swelling or numbness in your legs or buttocks or if you fall. Refer to the Instructions for Use provided on www.vertiflex.com for additional Indications for Use, contraindications information and potential adverse effects, warnings, and precautions prior to using this product. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

Indications for Use: The Boston Scientific Radiofrequency Generators, associated Radiofrequency Lesion Probes and RF Cannula are indicated for use in procedures to create radiofrequency lesions for the treatment of pain or for lesioning nerve tissue for functional neurosurgical procedures. The Boston Scientific RF Injection Electrodes are used for percutaneous nerve blocks with local anesthetic solution for radiofrequency lesioning of peripheral nerve tissue only. The Boston Scientific LCED and Stereotactic TCD Electrodes are indicated for use in radiofrequency (RF) heat lesioning of nervous tissue including the Central Nervous System.

Warnings: The Boston Scientific RF devices may cause interference with active devices such as neurostimulators, cardiac pacemakers, and defibrillators. Interference may affect the action of these active devices or may damage them. For appropriate guidance, consult the instructions for use for these active devices. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

§The physician locator tool identifies pain management specialists in your area who have met certain qualifying criteria and are experienced with one or more of Boston Scientific pain management therapies. All treatment options should be discussed thoroughly with a pain management specialist.