FDA has approved the commercial sale and distribution of the Mobi-C® Cervical Disc (Mobi-C).

It is official since this morning, LDR, a privately held medical device company has received a letter of approval from the U.S. Food and Drug Administration (FDA) allowing the commercial sale and distribution of the Mobi-C® Cervical Disc (Mobi-C), for one-level indications in the United States.

Connectikpeople may recall that, Mobi-C is a cobalt chromium
alloy and polyethylene, mobile-bearing prosthesis specifically designed as a bone-sparing, cervical intervertebral disc replacement.

According to LDR, Mobi-C has demonstrated non-inferiority in overall trial success compared to ACDF, which is a standard option for treating degenerative disc disease. Other findings included:

• Mobi-C implanted at one-level demonstrated non-inferiority in overall trial success compared to ACDF. The difference between Mobi-C’s overall success rate of 73.7% and ACDF’s rate of 65.3% represented statistical non-inferiority (p=0.0021).
• The rate of secondary surgery at the index level for Mobi-C was 1.2% versus 6.2% for ACDF.
• The percentage of subjects who reported negative radiographic changes from baseline in adjacent segments was:
• At the inferior adjacent level; 7.7% of Mobi-C patients compared to 21.0% of ACDF patients
• At the superior adjacent level; 14.6% of Mobi-C patients compared to 25.0% of ACDF patients.
• Mean return to work time was 29.3 days for Mobi-C compared to 36.8 days for ACDF.
• Mobi-C is a safe and effective surgical option at one-level in the cervical spine from C3-C7 for indicated patients.

 “The data from our study represents the latest Level I evidence supporting cervical disc replacement as an attractive treatment alternative to anterior cervical discectomy fusion (ACDF) for indicated patients. This approval is validation that LDR continues to introduce innovative and exclusive spine technologies designed to improve patient care.” said Christophe Lavigne, President and CEO of LDR.

About LDR

LDR, founded in Troyes, France and headquartered in Austin, Texas, is a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders. Exclusive LDR technologies are based on the Mobi non-fusion and VerteBRIDGE® fusion platforms which have applications in lumbar and cervical spine. In addition to Austin and Troyes, LDR has regional offices in Germany, Spain, China, Korea and Brazil.