LDR's primary products are based on its exclusive VerteBRIDGE fusion and Mobi non-fusion technology. Last year the company received the first FDA clearance for both one- and two-level cervical disc replacement with the Mobi-C Cervical Disc. In March, the American Medical Association CPT Editorial Panel accepted the addition of Category I code 22858X as an add-on code to support two-level cervical arthroplasty procedures, effective Jan. 1, 2015.
The Mobi-C is a cobalt chromium alloy and polyethylene, mobile-bearing prosthesis specifically designed as a bone-sparing, cervical intervertebral disc replacement.
"The Mobi-C IDE two-level data, including proof of 48-month statistical superiority in terms of the primary study outcome, is one of the most exciting developments in spine surgery in recent years. We feel that the growing body of long-term evidence on Mobi-C including what was presented at the ISASS annual meeting, further supports the role that this technology has in providing patients with a treatment alternative to fusion," said LDR President and CEO Christophe Lavigne in a company news release.
Here are five interesting findings from the studies presented at ISASS:
1. Michael Hisey, MD, of Texas Back Institute was the lead author on an article that won Best Clinical Paper at the meeting comparing sagittal alignment of one-level total disc replacement and anterior cervical discectomy and fusion patients. The study was a randomized, prospective clinical trial examining patients for 24 months. Dr. Hisey and his team found no significant difference between outcomes of C2-C7 lordotic and kyphotic Mobi-C patients at the 24-month follow-up.
2. A separate study examining the results from the FDA IDE Mobi-C clinical trial followed patients for 38 months and statistically validated Mobi-C at one-level. The Mobi-C overall study success was 69.5 percent at 48 months, versus ACDF at 58.7 percent for one-level procedures. Mobi-C had statistical superiority over ACDF specifically at 12 months and 36 months for the primary study endpoint, giving it a clear advantage over fusion.
3. Two-level artificial disc replacement also showed success over ACDF in a prospective, randomized clinical trial. At 48 months, the two-level Mobi-C overall study success was 66 percent, compared with 36 percent for two-level ACDF. Safety and efficacy were also significantly better with the artificial disc.
4. Hyun Bae, MD, presented a study comparing one-level and two-level cervical disc arthroplasty using Mobi-C in the FDA IDE clinical trial. After four years, Dr. Bae found no evidence of efficacy reduction or increased complications with Mobi-C as the number of levels treated increased from one to two. The rate of secondary surgery for one-level disc replacement was 3 percent and two-level disc replacement was 4 percent, compared with one- and two-level ACDF at 9.9 percent and 15.2 percent, respectively.
5. Self-reported outcomes showed significantly greater improvement for artificial disc replacement. The NDI item analysis showed improvement in personal care, work, headaches, reading, lifting and recreation headaches among patients in the Mobi-C group versus the ACDF group.
More Articles on Spine Surgery:
What the Future Holds for Cervical Disc Replacement: More Than a Passing Trend?
The Making of an Interactive Spine Registry: Dr. Zoher Ghogawala
6 Findings on How Obesity Impacts Spine Surgery Risks