CENTER VALLEY, Pa., May 8, 2017 /PRNewswire/ — Aesculap Implant Systems, LLC announced today that Dr. Richard Guyer of the Center for Disc Replacement at Texas Back Institute presented the adjacent segment disease (ASD) outcomes of the activL® Artificial Disc Investigational Device Exemption (IDE) trial at the International Society for the Advancement of Spine Surgery Annual Meeting (April 12-14, 2017, Boca Raton, FL). The data reiterates the role of lumbar total disc replacement in delaying the progression of ASD, a common downstream complication associated with lumbar fusion. ASD furthers the societal burden imposed by degenerative disc disease, a condition responsible for 62 million physician visits per year and the number two reason – second only to the common cold – for lost work time. The trial found that at five years, the activL Artificial Disc had a protective effect on the progression of DDD at adjacent levels in 91.2% of patients.
According to Dr. Guyer, former president of the North American Spine Society (NASS), “These outcomes complement the large body of evidence already available reporting on the long-term adjacent outcomes following lumbar disc replacement. Previously, lumbar fusion had been reported to be responsible for a rate of ASD as high as 28.6% in patients with five-year follow-up.”
In 2008, Harrop et al. published a systematic review of lumbar disc replacement data and reported that in patients with three to 22 years of follow-up, total disc replacement resulted in a 9% adjacent segment degeneration rate, whereas lumbar fusion resulted in a 34% rate. Later, in 2012, Zigler et al. worked with Medical Metrics Incorporated (MMI) to conduct a post-hoc analysis on ProDisc-L IDE subjects and found a three-fold reduction in ASD rates between lumbar TDR and fusion at five years. MMI employed the same methods used in Zigler et al., 2012 to analyze the ASD outcomes from the activL Artificial Disc IDE trial.
Until recently, patient access to lumbar arthroplasty, or total disc replacement, for patients suffering from symptomatic degenerative disc disease has been a challenge due to the lack of coverage on many insurance policies. However, outcomes such as those presented by Dr. Guyer have caused payers to reconsider their policies.
In May, national insurer Humana, which is responsible for insuring more than six million American lives, overturned their coverage determination for lumbar total disc replacement. This policy change, along with others, resulted in now nearly one in two privately-insured Americans having access to lumbar disc replacement. Additional long-term evidence will likely cause more payers to reconsider their stance in the coming months.
A group of surgeon investigators from the activL Artificial Disc IDE trial are currently compiling the full outcomes of this ASD analysis and are expected to seek publication of the full data set later this year.
SOURCE Aesculap Implant Systems, LLC