Intracept Basivertebral Nerve Ablation Procedure (Prod 11551)






About Intracept Basivertebral Nerve Ablation Procedure (Prod 11551)

Based on the research of Michael Heggeness, MD, PhD of the Baylor College of Medicine, Relievant's Intracept System treats chronic low back pain with a simple, minimally invasive procedure using radiofrequency energy delivered through a small access tube into the vertebral body to ablate the basiverterbal nerve. The nerve, which is believed to significantly contribute to chronic low back pain, no longer functions once it is ablated. There is no implant with the Intracept procedure, and based on a pilot study the treatment can usually be performed in about one hour.

The SMART trial (Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain) is a prospective, randomized, double-blind, sham-controlled investigation evaluating the reduction of pain in patients with chronic axial low back pain. The pivotal study will treat 200 patients at major medical centers around the United States with the Intracept System to determine the safety and effectiveness of this product. Enrollment in the SMART trial will begin this summer, with data analysis after the last subject has completed six months of follow-up.

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