CENTER VALLEY, Pa., Nov. 9, 2017 /PRNewswire/ — Aesculap Implant Systems, LLC today announced the significance of the long-term data presented at the NASS 2017 podium during the NASS Annual Meeting in Orlando, FL, October 25-27, 2017. At the meeting, three key presentations were made that greatly increase the body of evidence in support of lumbar total disc replacement (TDR) as a standard of care for a subpopulation of patients suffering from degenerative disc disease (DDD).
The five-year outcomes of the activL® Artificial Disc Investigational Device Exemption (IDE) Study, a 7-Year Multi-Center, Randomized Controlled Trial (RCT) which compares outcomes of the activL Artificial Disc and previous generation disc replacements such as ProDisc-L (DePuy Synthes) were presented by one of the co-investigators of the study, Jim Yue, MD (Quinnipiac University, New Haven, CT). The data demonstrates that while both the activL device and the control were effective at addressing patient pain and disability at five years, the activL device was more likely to preserve segmental range of motion at five years (p = 0.03) and had a higher safety profile (p < 0.001).
Additionally, the outcomes of a landmark 5-Year Meta-Analysis of RCTs comparing lumbar disc replacement to fusion were presented by Jack Zigler, MD (Texas Back Institute, Plano, TX). The meta-analysis demonstrated that TDR was superior to fusion at addressing patient disability, reoperation and satisfaction at five years (p=0.05, p=0.002, p=0.01, respectively).
During the data presentations, one audience member posed to the panel, “Is it your opinion that lumbar disc replacement can now be considered a gold standard of care for DDD?” Dr. Zigler replied, “It’s hard to reconcile that insurers still label lumbar TDR as experimental given this five-year level 1a data.” Members of the panel concluded that the evidence supported lumbar TDR as a standard of care that spine surgeons should be offering a subpopulation of their patients and that payers need to make accessible.
Later in the week, Richard Guyer, MD (Texas Back Institute, Plano, TX) presented one of the 21 papers nominated for Best Paper at NASS detailing the outcomes of an ad hoc analysis from the activL IDE study looking at the adjacent segment disease (ASD) outcomes between disc replacement systems at five years. From the analysis conducted by an independent third party, Dr. Guyer presented a 9% ASD rate for the activL device and a 19% rate for the control. The investigators are currently conducting additional data analysis to compare these TDR device outcomes to previously reported fusion ASD rates. Dr. Guyer also presented evidence of a correlation between the protective effect that range of motion has on ASD. “Finally, for those of us that have dedicated our careers to motion preservation, there is holy grail evidence that our theories were correct,” concluded Dr. Guyer from the podium.
The NASS abstracts are indexed and available for reference in The Spine Journal. The presenters and their co-authors are finalizing the full manuscripts relative to this data with the plan to present these outcomes to U.S. payers. In 2017, 16 million additional privately-insured patients now have a positive coverage policy giving them access to lumbar TDR.
About Aesculap Implant Systems, LLC
Aesculap Implant Systems, LLC, a B. Braun company, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com.
SOURCE Aesculap Implant Systems, LLC