New long-term data on the effect of lumbar total disc replacement on adjacent level degeneration reinforces outcomes from previous studies

The Spinal Kinetics M6 Disc Replacement offers a "Quality of Motion" that is not present in any other implant we have seen!

Unlike early Disc Replacement designs, the Spinal Kinetics M6 artificial disc is designed to replicate the structure and performance of a natural disc. Its innovative design incorporates an artificial nucleus to allow shock absorption and a woven fiber annulus for graded variable motion resistance in all directions.

These characteristics accurately replicate the natural disc, allowing the implant to work in concert with the remaining human discs. Unlike earlier "ball-in-socket" implants, with the M6 disc replacement the resulting natural functionality of the entire spinal curve will provide the best chance for a full recovery. In addition, future complications will be eliminated by reducing adjacent level degeneration and strain on the muscles and ligaments.



With improved implants Disc Replacement is now even better!
Advanced disc replacement implants now available offer improved safety
and a "Quality of Motion" that makes them truly deserve the title "Artificial Disc".

Our surgeons are now offering the breakthrough Spinal Kinetics M6 implant for the Cervical and Lumbar spine. The first disc replacement implant to truly deserve the title "Artificial Disc". This implant achieves the ultimate goal of replicating the healthy human disc. By providing shock absorption and graded variable motion resistance, the M6 works in concert with the remaining human discs, to provide the best possible outcome. This "Quality of Motion" is a major benefit not available in any other implant we have seen!

Are you confused about what treatment is the best option for you?
Maybe you have been told you are not a candidate for Disc Replacement. You could be considering a temporary solution like discetomy, laminectomy or laser surgery. Many are told that fusion is their only option in error.

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In order to determine what treatment is right for you, you need a comprehensive evaluation, done by our team of surgeons, who are experienced with the full range of globally available options.
We will provide you a complete written evaluation and surgery plan free of charge.

In the last decades medical technology has moved forward at a faster than ever pace. Yet many spine surgeons remain stuck in the past, limited by regulation they are still using fusion surgery or outdated disc replacement technology. Are you asking Disc Replacement versus Fusion Surgery?

Due to FDA restrictions, limitations of the approved products, and the inexperience of many surgeons, many patients will be exposed to unnecessary risk, get debilitating fusion surgery, or continue to suffer needlessly. Most, never knowing there are better options available, technology that can preserve the natural motion of the spine, and surgeons with the experience required to help them.

Why Disc Replacement versus fusion surgery?

There are several concerns with spinal fusion surgery. Overall success rates are very low and the recovery is long and painful. Even after a "successful" spinal fusion, problems begin to develop soon after the fusion surgery. The segments next to the Fusion Surgery have more forces applied causing "adjacent level degeneration" which studies have shown will lead to additional pain and surgeries.


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

http://www.prnewswire.com/news-releases/new-long-term-data-on-the-effect-of-lumbar-total-disc-replacement-on-adjacent-level-degeneration-reinforces-outcomes-from-previous-studies-300453436.html