The Food and Drug Administration (FDA) has approved LDR Holding Corporation’s Mobi-C Cervical Disc for one-level indications in the U.S.
The evidence from the clinical trial showed the device was non-inferior to fusion. But more significantly, patients with the disc returned to work a week faster than those who received a fusion.
According to a company spokesperson, the FDA previously gave conditional approval for two-level indications. The company is currently going through proper review channels. Once approved, the Mobi-C will be the first and only artificial cervical disc approved by the FDA for multi-level indications of degenerative disc disease in the U.S.
Alternative to Fusion
Christophe Lavigne, company president and CEO, said on August 8, 2013, the data from their 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.”
Mobi-C IDE Results
Mobi-C is a cobalt chromium alloy and polyethylene, mobile-bearing prosthesis specifically designed as a bone-sparing, cervical intervertebral disc replacement. In addition to the unique mobile-bearing feature, Mobi-C offers a simplified surgical technique as 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% and ACDF’s rate of 65.3% represented statistical non-inferiority (p=0.0021).
- The rate of secondary surgery at the index level for Mobi-C was 1.2% versus 6.2% for ACDF.
- The percentage of subjects who reported negative radiographic changes from baseline in adjacent segments was:
- At the inferior adjacent level; 7.7% of Mobi-C patients compared to 21.0% of ACDF patients
- At the superior adjacent level; 14.6% of Mobi-C patients compared to 25.0% of ACDF patients.
- Mean return to work time was 29.3 days for Mobi-C compared to 36.8 days for ACDF.
- Mobi-C is a safe and effective surgical option at one-level in the cervical spine from C3-C7 for indicated patients.
The controlled mobility of the Mobi-C’s mobile insert, according to the company’s website for Chinese surgeons, encourages restoration and respect of the instantaneous axis of rotation for a return to physiological mobility of the intervertebral disc and the cervical spine. The design also eliminates the need for invasive vertebral anchorage thus reducing the stresses on the bone-implant interface and facilitating multi-level implantations. The Mobi-C was first introduced in November 2004 and has now been used to treat thousands of patients worldwide. The device was approved in China in 2009.
Training and Sales
Lavigne said the company was now starting Mobi-C training and education program for surgeons. He also noted that 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.
LDR was founded in 2000 by partners Lavigne, Hervé Dinville, and Patrick Richard in Troyes, France. and is headquartered in Austin, Texas. The company designs and commercializes proprietary surgical technologies for the treatment of patients suffering from spine disorders. Exclusive LDR technologies are based on the Mobi non-fusion and VerteBRIDGE fusion platforms which have applications in lumbar and cervical spine. In addition to Austin and Troyes, LDR has regional offices in Germany, Spain, China, Korea and Brazil.
