Two-Level Cervical Disc Replacement: LDR's Journey to FDA Approval & the Next Step

Written by Heather Linder | August 29, 2013 | Print  |

LDR's Mobi-C cervical disc replacement recently received FDA market approval for two-level indications and became the first device to be endorsed for multiple level indications in the cervical spine.Worldwide, more than 17,000 patients already have had the device implanted.

"What is very unique about the approvals is the Mobi-C is the first and only device FDA approved for one- and two-level cervical discs," says Joe Ross, executive vice president of global marketing for LDR. "The study demonstrated overall clinical superiority based on the composite, primary endpoint for the Mobi-C for two-level disc replacements as compared to two-level anterior cervical discectomy and fusion."

The Mobi-C was developed in France in the early 2000s and was first used clinically in 2004, Mr. Ross says. The device's U.S. investigational device exemption (IDE) trials began in 2006. The company conducted concurrent, multi-center and randomized trials for one- and two-level indications.

The FDA pre-market approval process is arduous but produced an incredible amount of clinical data for the technology, Mr. Ross says. The FDA's in-depth review speaks to the quality of the study and the validity of the results.

"We are proud of having gone through the process with two trials that combined represent the largest study performed for cervical disc replacement," he says.

LDR's technology has the potential to be an important new treatment option, says Christophe Lavigne, the company's founder, president and CEO. The Mobi-C presents a new way to treat patients indicated for anterior cervical surgery, but physician education will be the important next step.

"We want to make sure surgeons in the U.S. will use the device for appropriate, on-label indications," he says. "Based on the results of the IDE study, Mobi-C for two-level applications demonstrated superiority over the fusion control procedure. We are hopeful that surgeons will embrace the technology."

Mr. Ross and Mr. Lavigne spoke to the device's intended benefits relative to the clinical trial data. Results showed patients with the Mobi-C were able to return to work nearly 21 days sooner than after an anterior cervical discectomy and fusion and had a 32.3 percent higher overall success rate.

Mr. Ross is also hopeful the U.S. reimbursement market will continue to develop favorably for cervical disc replacement.

"Reimbursement coverage for one-level cervical disc replacement has improved," he says. "We are looking forward to the data from the Mobi-C one and two-level clinical trials being available for review and consideration by the payer community."

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