Abstract
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.
Footnotes
Funding J.E.B. received funding to assist in the preparation of this manuscript from Intrinsic Therapeutics, Inc. (Woburn, MA, USA). This research received no additional external funding.
Declaration of Conflicting Interests The authors report no conflicts of interest in this work.
Disclosures Andrew Metzger reports consulting fees from Intrinsic Therapeutics. Betsy Grunch reports research support from Orthofix; royalties/licenses from Hyhte Holdings and Choice Spine; consulting fees from Brainlab, GT Medical Technologies, Nevro, Zimvie, OptimaSurgical, WebMD, Stryker, Corelink, Playback Health, Alevio, Spineology, and Orthofix; payment or honoraria from the Georgia Society of International Pain Physicians and the North American Neuromodulation Society; payment for expert testimony from various law firms; travel expenses from Georgia Society of Interventional Pain Physicians, the North American Neuromodulation Society, and NASS; leadership or fiduciary role for the Scientific Advisory Board for Spineology; stock from Spineology. William Watters reports consulting fees from Intrinsic and Change Health Care; payment for expert testimony from various entitites; participation in a data-monitoring board for Turning Point Health Care Solutions; and a leadership or fiduciary role for NASS and The Spine Journal. Gunnar Andersson reports consulting fees from Orthofix; participation in a data-monitoring board for Agnovos and Spineart; and a leadership or fiduciary role for as well as stock/stock options from Tetrous Inc. The remaining authors have nothing to disclose.
Author Contributions Conceptualization, M.P.L. and J.E.B.; methodology, J.E.B.; software, J.E.B.; validation, K.-U.L. and J.E.B.; formal analysis, J.E.B.; investigation, M.P.L. and J.E.B.; resources, M.P.L., K.-U.L., and J.E.B.; data curation, M.P.L., K.-U.L., and J.E.B.; writing—original draft preparation, J.E.B.; writing—review and editing, M.P.L., W.C.W., B.H.G., A.K.M., K.-U.L., J.E.B., and G.B.J.A.; visualization, J.E.B.; supervision, M.P.L. and J.E.B.; project administration, M.P.L., K.-U.L., and J.E.B.; funding acquisition, M.P.L. and J.E.B. All authors have read and agreed to the published version of the manuscript.
- This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2024 ISASS. To see more or order reprints or permissions, see http://ijssurgery.com.
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