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LDR's Christophe Lavigne talks Mobi-C, MIVo and more

During NASS 2015, LDR announced that FDA approved an update to labeling for the Mobi-C® cervical disc to include 5-year clinical results. The updated data remains consistent with the previous findings at 24 months—specifically, that at 60-month follow-up, Mobi-C is statistically non-inferior in overall study success for 1-level use, and statistically superior in overall study success compared to ACDF for 2-level use.

This update is critical because, in the words of Christophe Lavigne, LDR President and CEO, “In addition to bolstering the continued support from surgeons, the statistical superiority in overall success of Mobi-C to ACDF at two levels will serve as additional evidence to further the confidence of insurance payers in cervical disc replacement. This is a win for all patients indicated for the treatment.”

Earlier in October, LDR reported preliminary 3Q15 revenue of $39.3 million, +14% from 3Q14. Exclusive Cervical Technologies revenue of $27.5MM grew +25% year over year. Cervical product revenue continues to garner principal support from sales of Mobi-C. 

Mobi-C is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis designed as a bone-sparing, cervical intervertebral disc replacement, and is the only FDA-approved disc for 1-level and 2-level use.

In response to BONEZONE’s query on LDR’s future focus, Mr. Lavigne expanded upon the lumbar region:

“On the lumbar side, we do not believe the future of degenerative spine fusion surgery will rely on pedicle screw fixation. We view pedicle screws as the last fixation option most appropriate for advanced pathology, significant deformity or revision.

“Our vision for the evolution of 360° lumbar spine fusion surgery is to combine a stable interbody construct with a posterior MIS approach that avoids pedicle screws and rods. This can maximize the opportunity for clinical success while preserving the pedicles for more aggressive intervention that might be necessary in the future. One way to think about this approach is what we are now calling Minimal Implant Volume Surgery, or MIVo™ Surgery.

“Ultimately, this approach to lumbar instrumentation may result in a 45 percent to 60 percent reduction in the volume of implant material used to stabilize one level of the lumbar spine, while still providing adequate stability to both the anterior and posterior spinal columns and avoiding use of the vertebral pedicles.”

Mr. Lavigne offers an outlook on the future in BONEZONE’s Zoning In column.