Spinal technology company LDR, offers exclusive spinal implant technologies for both non-fusion and fusion applications. Now the company has announced that it has received U.S. FDA approval for the commercial sale and distribution of its Mobi-C® Cervical Disc (Mobi-C), for one-level indications in the United States.
LDR focuses on designing and commercializing novel and 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.
Mobi-C is a cobalt chromium alloy and polyethylene, mobile-bearing prosthesis specifically designed as a bone-sparing, cervical intervertebral disc replacement. Manufacturer, LDR says that in addition to the unique mobile-bearing feature, Mobi-C offers a simplified surgical technique, compared with other commercially available devices.
The FDA’s decision to approve Mobi-C for one level indications is based on results from the one-level arm of the Investigational Device Exemption (IDE) trial. Mobi-C demonstrated non-inferiority in overall trial success and at one-leve implantation compared to Anterior Cervical Discectomy and Fusion (ACDF), a standard option for treating degenerative disc disease. Other findings at the 24-month endpoint included a rate of secondary surgery at the index level for Mobi-C of 1.2% versus 6.2% for ACDF, a lower incidence of negative radiographic changes (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) and a mean return to work time of 29.3 days for Mobi-C compared to 36.8 days for ACDF.
“The data from the one-level Mobi-C trial adds to the extensive library of evidence supporting cervical disc replacement as an attractive alternative to anterior cervical fusion,” said Dr. Michael Hisey of the Texas Back Institute, Plano, Texas. “I am very pleased now that Mobi-C is approved for one-level indications, as I will have the opportunity to offer my patients a state-of-the-art treatment option that will address their symptoms while providing the potential to maintain normal spinal motion.”
“We are pleased that the FDA, after an intensive review of our Pre-Market Application (PMA), has determined that Mobi-C is safe and effective for one-level cervical disc replacement in the United States,” said Christophe Lavigne, President and CEO of LDR. “The data from our 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 designed to improve patient care.”
“We are very proud to be one of the few companies to have successfully obtained FDA approval for a cervical artificial disc device with one-level indications. I want to thank those involved in this study for their incredible support, especially the patient participants,” continued Lavigne. “We are now starting our US Mobi-C training and education program for surgeons, and are very excited to enter this market. 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.”
Source: LDR, Business Wire