Barricaid is the only FDA PMA-approved technology indicated for annular closure on the market.
Barricaid’s path to FDA approval for use in the United States involved the treatment of thousands of patients over a ten-year period, studies of seven distinct patient populations (including a level-I randomized study), and 50+ peer-reviewed publications. Throughout these multi-year studies, Barricaid has consistently achieved excellent results and superior outcomes when compared to discectomy alone.
A 554-patient, level-I clinical study leading to FDA Pre-Market Approval published in The Spine Journal 18 (2018) 2278–22872 reported that Barricaid patients in this study steadily outperformed non-Barricaid patients in freedom from symptomatic reherniation at three-month, six-month, one-year, and two-year follow ups. A 2019 article published in World Neurosurgery3 indicates that patients who received the Barricaid ACD had more favorable clinical outcomes for symptomatic reherniation (50% lower rate) and reoperation (43% lower rate) at three-year follow ups. Those patients also reported better outcomes related to leg pain, back pain, and the Oswestry Disability Index (ODI).
Barricaid is indicated for skeletally mature patients with radiculopathy (with or without back pain) attributed to a posterior or posterolateral herniation at a disc with at least 5mm of disc height. The implant comes in two sizes and is specifically designed to treat annular defects between 4 – 6mm tall and 6 – 10mm wide at a single level between L4 and S1. Patient history, physical examination, and imaging studies will help you determine the suitability of Barricaid for any given patient.