The cervical disc market has been relatively quiet in recent years, but recent FDA approvals have once again started to get the artificial disc market moving. The first two cervical discs, the Prestige (Medtronic) and ProDisc-C (Synthes) and the Bryan (Medtronic), were approved by the FDA in 2007 and 2009, respectively. However, no new cervical discs were approved until this year. Between September and October 2012, the FDA granted two new cervical discs premarket approval (PMA), with two other discs expecting approval soon.
Expanding clinical evidence
Unlike traditional spinal fusions, artificial discs preserve motion and flexibility in the affected area of the spine. Companies and academics have spent years generating data on clinical efficacy and complication rates for cervical disc arthroplasty compared to anterior cervical discectomy and fusion (ACDF), and results of these studies were a hot topic at this year’s North American Spine Society (NASS) meeting.
One study presented at NASS compared reoperation rates for 51 patients undergoing anterior cervical fusion and 84 patients who received a cervical total disc replacement in one of six different randomized IDE trials. Each trial used a different disc (ProDisc-C, KineflexC, Mobi-C, Neodisc, Discover, or Advent), and the study demonstrated significantly reduced reoperation rates overall for patients undergoing cervical disc replacement compared to fusion (6.0% vs. 17.6%; p < 0.05).
Multiple studies have shown similar outcomes for reoperation rates as well as for improved clinical outcomes with cervical disc arthroplasty compared to fusion, and this growing body of evidence for cervical discs led to a number of new devices entering the market. Technology Insights neuroscience researchers discussed these trials during the recent teleconference roundup highlighting presentations at the NASS Annual Meeting. Additional insight and coverage can be found here.
Globus Medical’s SECURE-C
In September 2012, the SECURE-C became the first cervical disc to receive FDA approval since 2009. The disc is comprised of cobalt-chrome endplates and a central polyethylene core, and is indicated in skeletally mature patients for reconstruction of the disc at one level from C3-C7 following single-level discectomy for certain conditions. Globus Medical received approval for its product following positive results of a prospective, randomized IDE study comparing the safety and effectiveness of the SECURE-C to ACDF.
The study demonstrated significantly greater overall success results for the SECURE-C compared to fusion at 24 months (90.1% vs. 71.1%), as well as superior rates of subsequent surgery at the index level, device-related adverse events, adjacent level surgery, and patient satisfaction.
Just one month after SECURE-C received its PMA, the FDA granted approval for NuVasive’s PCM cervical disc. This disc is also composed of cobalt chrome endplates and a central polyethylene core, and is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single level discectomy for certain conditions.
The two-year results of PCM’s IDE trial, conducted at 23 investigational sites across the United States, demonstrated non-inferiority for PCM compared to fusion in all primary and secondary endpoints.
New cervical discs on the horizon
Two more cervical discs–Mobi-C (LDR Spine Inc) and Kineflex-C (SpinalMotion Inc)–are set for FDA premarket approval in the near future. LDR received a conditional approval letter from the FDA in November 2012 and is expected to receive full approval for the Mobi-C in 2013. The Mobi-C will be the first artificial disc approved for two-level indications. SpinalMotion submitted its PMA application for the Kineflex-C in 2010 and is hoping to follow the Mobi-C as the next cervical disc to be approved.
Technology Insights will be closely monitoring the cervical disc approval process, so stay tuned to The Pipeline for all the latest information on spine technology.