Medical device company LDR Holding has announced the presentation of 48-month safety and efficacy data of both one-level and two-level cervical disc replacement with Mobi-C when compared to anterior cervical discectomy and fusion (ACDF).
Cedars-Sinai medical director Dr Hyun Bae presented the 48-month safety and efficacy data of both one-level and two-level cervical disc replacement with Mobi-C at the North American Spine Society Annual Meeting.
The data presented by Dr Bae included mean neck disability index (NDI) scores, reoperation rates, and mean range of motion.
In both the one-level and two-level Mobi-C patient cohorts, the mean NDI scores and improvement is similar.
The reoperation rates at 48 months were 3.0% and 4.0% for the one and two-level Mobi-C patients, while the reoperation rates were 9.9% and 15.2% for the ACDF patients.
In both the one-level and two-level Mobi-C patient cohorts, mean range of motion has been maintained through 48 months at the operative levels.
When compared to the one-level ACDF patients, two-level ACDF patients showed statistically significantly less NDI improvement through 48 months.
LDR's Mobi-C is a cobalt chromium alloy and polyethylene, mobile-bearing prosthesis, which offers a simplified surgical technique when compared to other devices.
The Mobi-C has been specifically designed as a bone-sparing, cervical intervertebral disc replacement for both one and two-level indications.
Recently, LDR's Mobi-C cervical disc replacement device obtained approval from the US Food and Drug Administration.
