Relievant Medsystems enrolled the first patient in its clinical study analyzing the Intracept procedure, a minimally invasive approach to treating low back pain.
Here are four things to know:
1. The INTRACEPT study is a Level 1, prospective, randomized clinical trial evaluating the efficacy of the Intracept procedure to conservative treatments in treating chronic low back pain. Relievant plans to enroll up to 150 patients spanning 20 U.S. centers in the clinical trial.
2. Researchers will analyze the mean change from baseline compared to three months following treatment in the Oswestry Disability Index.
3. Steven Garfin, MD, department of orthopedic surgery chairman at the University of California, San Diego Medical Center, is the study's principal investigator. Previously the president of the North American Spine Society, Dr. Garfin has been actively involved in creating and assessing spinal disorder treatments.
4. The company's Intracept System has FDA 510(k) clearance.