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.