LDR Gets FDA OK for Cervical Disc Replacement Device

The U.S. Food and Drug Administration (FDA) issued an approval letter to LDR for the Mobi-C Cervical Disc replacement for one-level indications in the cervical spine from C3-C7.

“We are pleased that the FDA, after an intensive review of our pre-market application (PMA), has determined that Mobi-C is safe and effective for one-level cervical disc replacement in the United States,” said Christophe Lavigne, president and CEO of LDR. “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.”

Traditional cervical fusion procedures involve neck surgery during which two or more vertebral segments of the cervical spine are fused together with the goal of eliminating painful cervical neck motion, instability and providing additional space for the decompressed spinal cord and nerves.

Mobi-C is a cobalt chromium alloy and polyethylene, mobile-bearing prosthesis specifically designed as a bone-sparing, cervical intervertebral disc replacement. According to the company, in addition to its unique mobile-bearing feature, Mobi-C offers “a simplified surgical technique compared to other commercially available devices.”

In the one-level arm of the investigational device exemption (IDE) trial, Mobi-C demonstrated non-inferiority in overall trial success compared to ACDF, which is a standard option for treating degenerative disc disease.

Other findings comparing Mobi-C to ACDF in the one-level arm at the 24-month endpoint 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 percent and ACDF’s rate of 65.3 percent represented statistical non-inferiority (p=0.0021).
• The rate of secondary surgery at the index level for Mobi-C was 1.2 percent versus 6.2 percent for ACDF.
• The percentage of subjects who reported negative radiographic changes from baseline in adjacent segments was:
• At the inferior adjacent level; 7.7 percent of Mobi-C patients compared to 21 percent of ACDF patients
• At the superior adjacent level; 14.6 percent of Mobi-C patients compared to 25 percent of ACDF patients.
• Mean return to work time was 29.3 days for Mobi-C compared to 36.8 days for ACDF.

“We are very proud to be one of the few companies to have successfully obtained FDA approval for a cervical artificial disc device with one-level indications. I want to thank those involved in this study for their incredible support, especially the patient participants,” continued Lavigne. “We are now starting our U.S. Mobi-C training and education program for surgeons, and are very excited to enter this market. Mobi-C is now the only cervical disc available to non-captive, independent U.S. sales agents, giving them the unique ability to strengthen their presence with their customers.”

“The data from the one-level Mobi-C trial adds to the extensive library of evidence supporting cervical disc replacement as an attractive alternative to anterior cervical fusion,” said Michael Hisey, M.D., of the Texas Back Institute, Plano, Texas, and an investigator of the Mobi-C. “I am very pleased now that Mobi-C is approved for one-level indications, as I will have the opportunity to offer my patients a state-of-the-art treatment option that will address their symptoms while providing the potential to maintain normal spinal motion.”

In addition to the full approval of Mobi-C for one-level indications, LDR also previously received conditional approval from the FDA for two-level indications, and is currently going through the proper review channels, the company reported.

LDR was founded in Troyes, France, and is headquartered in Austin, Texas. The company makes surgical technologies for the treatment of spine disorders.