22 years of disc replacement in the US: A timeline of milestones and challenges

Carly Behm -  

From milestone surgeries to emerging data and ongoing challenges, here is how artificial disc technology has developed in the last several decades:

Late 1980s: Physicians with Plano-based Texas Back Institute travels to Germany to learn more about the Charité artificial disc. 

March 2000: Scott Blumenthal, MD, performs the first artificial disc replacement in the U.S. with Charité as part of an FDA trial at Texas Back Institute in Plano.

October 2001: Jack Zigler, MD, performs the first lumbar ADR in the U.S with prodisc L as part of an FDA trial at Texas Back Institute in Plano.

September 2015: A patient who underwent artificial cervical disc replacement surgery sues Blue Shield of California for refusing to cover the procedure. 

February 2019: The FDA approves the M6-C artificial disc.

April 2020: The FDA approves Centinel Spine's prodisc L artificial disc for two-level indications, the only total disc replacement system in the U.S. approved for two-level use in the lumbar spine.

April 2021: The FDA approves NuVasive's Simplify cervical artificial disc for two-level total disc replacement.

May 2021: Orthofix releases three- and four-year preliminary outcomes from its M6-C artificial cervical disc single-level clinical trial. A greater percentage of M6-C disc patients experienced an improvement in Neck Disability Index scores at three and four years compared to the patients who had an anterior cervical discectomy and fusion. Four-year results were significantly better for the M6-C group.

July 2021: Seven-year data for the ActivL Artificial Disc is published.

September 2021: More than 60,000 M6-C artificial discs have been implanted worldwide by this time.

October 2021: Aetna Life Insurance is denied a petition for an immediate appeal in a 239-person class-action lawsuit. The 2019 lawsuit alleged Aetna denied coverage for artificial disc replacement surgery, saying the procedure was "experimental or investigational." The lawsuit was initially dismissed. 

November 2021: The American Medical Association accepts a new CPT add-on code for the second level of lumbar total disc replacement procedures. That code will go into effect in January 2023.

January 2022: Texas Back Institute completes its 3,000th lumbar artificial disc replacement.

April 2022: Two active NHL players who underwent ADR in late 2021 return to the ice months after the procedure. Robert Bray Jr., MD, said the NHL has effectively set a precedent for high-contact professional athletes to be considered for disc replacement.

Also, Market researchers forecast that the global artificial disc market will jump to $6.3 billion by 2027. The artificial disc market is valued at $2.6 billion in 2022.

March 2022: A lawsuit is filed against Aetna Life Insurance, arguing the insurer improperly limits coverage for lumbar artificial disc replacement by treating the procedures as experimental and investigational. Plaintiff Andrew Howard suffered from disc disease at L5-S1 that caused significant pain and mobility, and conservative measures such as medication and corrective exercises did not provide adequate relief, according to court documents. Robert Bray Jr., MD, recommended Mr. Howard undergo lumbar ADR, but Aetna denied the request and the patient had to pay for the procedures out of his own pocket.

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