First FDA Approval for Two-Level Cervical Disc Replacement

We’ve covered spinal device company LDR a few times on our pages, most recently earlier this month when its Mobi-C® Cervical Disc gained U.S.FDA approval for use in one-level spinal indications. Hot on the heels of that announcement it has received approval allowing the commercial sale and distribution of the product for two-level indications, making it the first and only cervical disc in the United States approved to treat more than one level of the cervical spine.

Background

Mobi-C is a cobalt chromium alloy and polyethylene, mobile-bearing prosthesis specifically designed as a bone-sparing, cervical intervertebral disc replacement, now indicated for both one and two-level indications. LDR says Mobi-C offers a simplified surgical technique as compared to other, commercially available devices, all of which are approved for one-level use only.

The approval has been supported by clinical trials: 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 statistical superiority in overall trial success compared to ACDF. Furthermore the rate of secondary surgery at the index level for Mobi-Cwas 3.1% versus 11.4% for ACDF.

Physician comments

“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,” said Dr. Reginald Davis, Director of Neurosciences at GMBC in Baltimore, Maryland. “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,” said 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.”

Company comments

“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,” said 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.”

“This has been a long and rewarding process,” continued Lavigne. “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.”

Source: LDR, Inc., Business Wire