Officials from LDR, a medical device company, announced that the 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 two-level indications. This approval makes this device the first and only cervical disc in the United States approved to treat more than one level of the cervical spine. LDR previously received a letter of approval on August 7, 2013 from the FDA allowing the commercial sale and distribution of the Mobi-C for one-level use.
“We are very pleased that the FDA, after an intensive review of our submissions, has determined that Mobi-C is safe and effective for both one and two-level indications in the United States, and superior to fusion for two-level cervical disc replacement, based on the results of our prospective, concurrently controlled and randomized, multi-center clinical trials,” says Christophe Lavigne, president and CEO of LDR. “We are proud that LDR is first to offer an on-label, arthroplasty solution for the significant number of patients suffering from two-level cervical disc disease. It is very gratifying to know that spine surgeons can now offer this new, evidence-based treatment option to their two-level surgical candidates.”
Mobi-C is a cobalt chromium alloy and polyethylene, mobile-bearing prosthesis specifically designed as a bone-sparing, cervical intervertebral disc replacement for both one and two-level indications. In addition to the unique mobile-bearing feature, Mobi-C offers a simplified surgical technique as compared to other, commercially available devices, all of which are approved for one-level use only.
In the two-level arm of the Investigational Device Exemption (IDE) trial, Mobi-C demonstrated superiority in overall trial success compared to anterior cervical discectomy and fusion (ACDF), which is a standard option for treating cervical degenerative disc disease. Specific findings comparing Mobi-C to ACDF in the two-level study at the 24-month endpoint included:
- Mobi-C implanted at two contiguous levels demonstrated statistical superiority in overall trial success compared to ACDF. The difference between Mobi-C’s overall success rate of 69.7% and ACDF’s rate of 37.4% represented statistical superiority. (P110009)
- The rate of secondary surgery at the index level for Mobi-Cwas 3.1% versus 11.4% for ACDF.
- The percentage of subjects who demonstrated negative radiographic changes from baseline in adjacent segments was:
- 2.9% of Mobi-C patients compared to 18.1% of ACDF patients at the inferior adjacent level; and
- 13.1% of Mobi-C patients compared to 33.3% of ACDF patients at the superior adjacent level.
- Mean return to work time was 45.9 days for Mobi-C compared to 66.8 days for ACDF.
- Mobi-C showed 78.2% improvement in Neck Disability Index (NDI) based on success criteria versus 61.8% for ACDF.
- Mobi-C is a safe and effective surgical option at two contiguous levels in the cervical spine from C3-C7 for indicated patients.
“The study data supporting the FDA Approval for Mobi-C represents Level I evidence – the highest level of data classification achievable in the field of Evidence Based Medicine,” states Dr. Reginald Davis, director of Neurosciences at GMBC in Baltimore, Md. “As a spine surgeon I have been following the positive clinical data supporting cervical disc replacement over the last several years including the long term evidence. I believe that the two-level Mobi-C study conclusions represent a landmark event in spine, as for the first time it has been demonstrated that on-label two-level cervical disc replacement with Mobi-C represents a superior treatment to two-level anterior spinal fusion.”
“Mobi-C is unique in that it is now the only cervical disc replacement FDA approved for both one and two-level clinical use,” notes Dr. Gregory A. Hoffman, orthopedic surgeon and member of the SpineONE Medical Team at Ortho North East in Fort Wayne, Indiana. “The population of patients suffering from one or two-level cervical disc disease is large, and Mobi-C has the potential to make a significant and positive impact to the treatment of those patients.”
“This has been a long and rewarding process,” Lavigne continues. “I would like to thank and attribute this success to everyone involved in this study, especially the clinicians, study coordinators, the FDA, LDR employees, our partners and suppliers, and most importantly the patients who consented to participate in the first concurrent one and two-level prospective study performed comparing cervical disc replacement to ACDF.”
The Summary of Safety and Effectiveness for P110009 is available at www.fda.gov.