Relievant Medsystem’s Intracept System is based on groundbreaking anatomic research that identified and demonstrated the role of the basivertebral nerve (BVN) in generating low back pain from the vertebral body endplates. The procedure uses a trans-pedicular, minimally invasive approach to reach the BVN near the center of the vertebral body, and uses radiofrequency energy to ablate the nerve; once ablated, these nerves no longer transmit pain signals. Dr. Giuffrida performs the Intracept Procedure under image guidance in the outpatient setting, with the entire procedure taking approximately 80 minutes. Treated patients report nearly immediate relief of their back pain. The Intracept 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 either Type 1 or Type 2 Modic changes on an MRI.
Intracept is a minimally invasive procedure that integrates two decades of scientific research on the basivertebral nerve and its role in CLBP. Following a small incision, instruments and Xray guidance is used to reach the basivertebral nerve. Once the correct position is verified radiofrequency energy, or heat, ablates the basivertebral nerve which in turn will stop the transmission of pain signals. Intracept is an outpatient procedure, which does not involve an implant or change the structure of the spine.
Low Back Pain (Chronic)
History of low back pain of at least 6 months duration (include the actual duration); and failed to respond to at least 6 months of non-surgical management (documenting the types of treatment); MRI demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from L3 to S1; and activities of daily living that are limited by persistent low back pain; and – All other reasonable sources of pain have been ruled out.
Low back pain is the most expensive occupational disorder in the United States and a leading cause of disability worldwide. CLBP impacts approximately 30 million people in the United States with nearly 900,000 new occurrences each year. The majority of CLBP sufferers do not get adequate relief from conservative treatments and are not surgical candidates. Today, nearly 80 percent of CLBP sufferers fail to find pain relief with available treatments. One cause of CLBP is microfractures of the vertebral body endplates. Back injury, genetic makeup, and other factors can cause degeneration of the spine, placing stress on the vertebral
body endplates. The stress on the endplates can lead to microfractures. The basivertebral nerve is located within the vertebral body and transmits pain from the vertebral body endplates causing CLBP.