LDR Gets First FDA Approval for Two-Level Cervical Disc Replacement
The folks at privately held LDR are checking off lots of items on their to-do list. In fact, the company won’t be private for long.
First off, the Austin, Texas-based spinal implant company recently received a letter of approval from the U.S. Food and Drug Administration (FDA) for two-level indication for the Mobi-C Cervical Disc implant. The company claims this makes the system the first and only cervical disc in the United States approved to treat more than one level of the cervical spine. As recently as August 7, LDR previously received an approval letter
from the FDA for 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,” 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.”
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, company officials claims that 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 trial, the company reported that 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 percent and ACDF’s rate of 37.4 percent represented statistical superiority;
• The rate of secondary surgery at the index level for Mobi-C was 3.1 percent versus 11.4 percent for ACDF;
• The percentage of subjects who demonstrated negative radiographic changes from baseline in adjacent segments was 2.9 percnet of Mobi-C patients compared to 18.1 percent of ACDF patients at the inferior adjacent level and 13.1 percent of Mobi-C patients compared to 33.3 percent 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 percent improvement in Neck Disability Index based on success criteria versus 61.8 percent for ACDF; and
• 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,” said Reginald Davis, M.D., director of Neurosciences at the Greater Baltimore Medical Center 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.”
“This has been a long and rewarding process,” Lavigne added. “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.”
In the midst of landmark product approvals for the company, LDR’s powers that be also plan on an initial public offering. The company recently filed the appropriate paperwork with the U.S. Securities and Exchange Commission. The number of shares to be offered and the price range for the proposed offering have yet to be determined. LDR plans to list its common stock on the NASDAQ Global Select Market under the ticker symbol “LDRH.”
Founded in Troyes, France, and headquartered in Austin, LDR also has regional offices in Germany, Spain, China, Korea and Brazil.