Artificial disc replacement is gaining popularity, proving to be a safe and effective motion-sparing alternative to spinal fusion. Approved for cervical and lumbar regions, the procedure involves replacing a degenerated disc with a prosthesis.
Here are 15 things to know about the field.
1. The global cervical artificial discs market is set to grow at a compound annual growth rate of 22.53 percent through 2020, according to a Research and Markets report. Utilizing surface-modified titanium for cervical spine implants is gaining traction over stainless steel.
2. North America dominates the cervical total disc replacement device market because of strong reimbursement policies and a jump in the amount of cervical disc replacement procedures performed, according to a Reportlinker analysis.
3. Although the hospital segment led the cervical total disc replacement device market in terms of end-user in 2014, ambulatory surgery centers are anticipated to grow at a higher compound annual growth rate through 2021. This growth in ASCs is due to patient demand for quick discharge and lower costs. Check out 26 ASCs pioneering on this front, here.
4. The metal-on-biocompatible material segment accounts for the greatest CTDR device market share, above metal-on-metal, identifies to Reportlinker. This is due to the material yielding a greater rotation degree and flexibility of the spine.
5. Reportlinker identifies the following as key cervical total disc replacement device market players: Dublin, Ireland-based Medtronic; Raynham, Mass.-based DePuy Synthes; Audubon, Pa.-based Globus Medical; San Diego-based NuVasive; and Warsaw, Ind.-based Zimmer Biomet.
6. With the growing popularity of non-fusion procedures, many companies have started developing devices for artificial disc replacement, dynamic stabilization and interspinous process decompression, based on a Market Research report.
7. Warsaw, Ind.-based Zimmer Biomet's Mobi-C technology earned FDA approval in 2013 as the first disc indicated for one- and two-level disc replacements. LDR, which Zimmer Biomet acquired in 2016 for $1 billion, developed the Mobi-C in the early 2000s and clinically tested it in 2004.
U.S. investigational device exemption trials started in 2006, finding two-level disc replacement superior to fusion at two- and five-year follow-up. Surgeons have implanted more than 40,000 Mobi-C discs in 25 countries.
8. In October 2016, Anthem BlueCross and BlueShield updated its coverage policy to include one- and two-level cervical total disc replacements performed with the Mobi-C. The payer also provided coverage for one-level disc replacements using the Bryan cervical disc, PCM cervical disc, ProDisc-C and the Prestige cervical disc, which received FDA approval in 2007.
9. In July 2016, Dublin, Ireland-based Medtronic received FDA clearance for its Prestige LP Cervical Disc. The device was cleared to treat cervical disc disease at two adjacent levels between the C3-C7 segments. Medtronic's first disc cleared for both one- and two-level procedures, Prestige LP has demonstrated greater rates in overall success (78.6 percent) compared to patients treated with two-level anterior cervical discectomy and fusion (62.7 percent).
10. Todd Lanman, MD, of Beverly Hills, Calif.-based Lanman Spinal Neurosurgery, highlighted his 4D Health Approach for one- and two-level total disc replacement in March 2017. The holistic approach takes into consideration a patient's overall health, ailments, environment and future aspirations. Dr. Lanman served as the principal investigator on the FDA trial testing the Prestige LP disc.
11. DePuy Synthes offers the ProDisc-C Total Disc Replacement device, indicated for treatment of a single degenerated cervical disc between C3-C7 segments, as well as the ProDisc-L total disc replacement device, indicated for treatment of a single degenerated lumbar disc between L2-S1 segments.
12. A 2015 study published in Spine compared costs for cervical disc replacement versus anterior cervical discectomy and fusion.The fusion group saw a higher reoperation rate at 36 months compared to the disc replacement group; 10.5 percent of the fusion group needed reoperations, compared to 5.7 percent of the disc replacement group. Index surgery costs were significantly lower for the disc replacement group. Insurers paid $34,979 for the disc replacement patients, compared to $39,820 for the fusion patients. Researchers concluded, "CDA was effective in reducing the monthly cost of care compared with ACDF."
13. A 2015 study published in The Spine Journal investigated outcomes for patients who underwent artificial disc replacement versus fusions for cervical radiculopathy. Researchers noted no significant differences between the two groups in terms of Neck Disability Index values, with 39.1 for disc replacement and 40.1 for spinal fusion. Complication rates also proved similar between the two groups. The study authors concluded, "Artificial disc replacement did not result in better outcome compared to fusion measured with Neck Disability Index two years after surgery."
14. Scott Blumenthal, MD, of Plano-based Texas Back Institute, performed the first lumbar disc replacement in the nation. He believes the cervical artificial disc will soon become the standard for a herniated disc.
He has observed increased "coverage for two-level cervical artificial disc replacement from major insurance carriers in the last year, giving more patients more options."
15. J. Brian Gill, MD, of Nebraska Spine Hospital in Omaha, says "lumbar disc replacement interest has continued to wane, but cervical disc replacements are gaining significant interest as the long-term results are promising." He emphasizes the importance of multilevel-use indication for cervical disc replacements, as many patients experience more than one-level complications.