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While achieving premarket approval from the US Food and Drug Administration represents a significant milestone in the development and commercialization of a Class III medical device, the aftermath endeavor of gaining market access can be daunting. This article provides a case study of the Barricaid annular closure device (Barricaid), a reherniation reduction device, which has been demonstrated to decrease the risk of suffering a recurrent lumbar intervertebral disc herniation. Following Food and Drug Administration approval, clinical adoption has been slow due to barriers to market access, including the perception of low-quality clinical evidence, questionable significance of the medical necessity of the procedure, and imaging evidence of increased likelihood of vertebral endplate changes. The aim of this article is to provide appropriate examination, rationale, and rebuttal of these concerns. Weighing the compendium of evidence, we offer a definition of a separate and unique current procedural terminology code to delineate this procedure. Adoption of this code will help to streamline the processing of claims and support the conduct of research, the evaluation of health care utilization, and the development of appropriate medical guidelines. [ABSTRACT FROM AUTHOR]

The National Institute for Occupational Safety and Health suggests there is insufficient biomechanical or epidemiological evidence to recommend the use of back belts in industry. From a biomechanical perspective, previous […]

Background: With advancing stages of degeneration, denaturation and degradation of proteoglycans in the nucleus pulposus (NP) lead to tissue dehydration and signal intensity loss on T2-weighted MR images. Pfirrmann grading is widely used for grading degeneration of intervertebral discs (IVDs). The criterion to differentiate IVDs of Pfirrmann Grade I from the other grades is NP homogeneity. Pfirrmann grading is qualitative and its assessment may be subjective. Therefore, assessment of quantitative objective measures correlating with early disc degeneration may complement the grading. This study aimed to evaluate the applicability of the distance between the center weighted by signal intensity (weighted center) and the geometric center as a parameter of NP homogeneity. Other phenomena related to advancing stages of degeneration were also investigated.Methods: MR images of 65 asymptomatic volunteers with a total of 288 lumbar IVDs with clearly identifiable nucleus pulposus boundary (Pfirrmann Grade I, II and III) were included in this study. A custom-written program was developed to determine the IVD longitudinal axis, define the NP boundary, and to locate the coordinates of geometric and weighted NP centers on the mid-sagittal image of each studied IVD. The distances between the weighted and geometric centers on the longitudinal axis and the perpendicular axis of each IVD were calculated.Results: The weighted center located posterior to the geometric center, which indicated the signal intensity was lower at the anterior portion of the NP, in 85.8% of studied IVDs. The distance between the weighted and geometric center on the longitudinal axis was significantly shorter in homogeneous (Pfirrmann Grade I) than in inhomogeneous (Grade II) IVDs. The distance on the perpendicular axis in Grade III IVDs was significantly larger than that in Grade I and Grade II IVDs.Conclusion: The relationship between the weighted and geometric centers can serve as an indicator for NP homogeneity. The distance between both centers through advancing stages of degeneration demonstrated decrease of signal intensity progressing along the longitudinal axis initially and then along the cranio-caudal direction at later stages. These findings could provide insights of initiation and subsequent progression of degenerative changes in IVDs. [ABSTRACT FROM AUTHOR]