The Food and Drug Administration (FDA) has given Investigational Device Exemption (IDE) approval to Relievant Medsystems to begin their SMART pivotal trial to evaluate the safety and effectiveness of the Intracept system for treatment of chronic low back pain.
The SMART trial (Surgical multicentre assessment of radiofrequency ablation for the treatment of vertebrogenic back pain) is a prospective, randomised, double-blind, sham-controlled investigation evaluating the reduction of pain in patients with chronic axial low back pain. It will enrol 200 patients at major medical centres around the United States.
Based on the research of Michael Heggeness, Baylor College of Medicine, the 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. 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 Intracept procedure may be a viable treatment alternative for patients suffering from axial low back pain who no longer respond to conservative therapies.
“Relievant’s Intracept procedure is simple, easy to perform, and the results seen in the pilot study are encouraging,” said Jeffrey S Fischgrund, principal investigator of the trial from the William Beaumont School of Medicine, Oakland University, Michigan, USA. “Given the ineffectiveness or limitations of existing options that are available to this very large, underserved group of suffering patients, Intracept could represent one of the most significant advances in the treatment of chronic low back pain. The SMART trial is designed to provide level 1 clinical evidence in determining the safety and effectiveness of the Intracept procedure.”
“In the initial pilot study of the Intracept system, treated patients reported immediate relief and were able to resume normal activities the next day,” stated Adam Savakus, president and CEO of Relievant Medsystems. “We look forward to working with some of the leading spine specialists in the United States to investigate this promising technology and providing definitive results in our pivotal trial.”