LDR, a privately held medical device company offering spinal implants for both non-fusion and fusion applications, recently announced the January 14th submission of a PMA for its single-level Mobi-C cervical artificial disc to the FDA.
As only one of two companies to have completed enrollment and 2-year follow-up for one- and two-level cervical artificial disc replacement studies, LDR said it has reached another important milestone. “It is extremely satisfying to submit the study results to the FDA and we are very pleased with the preliminary study outcomes,” Christophe Lavigne, president and CEO of LDR, stated in a press release announcing the submission.
Since its introduction in 2004, the Mobi-C cervical disc has been implanted in over 10,000 patients outside the United States. The IDE study results represent additional clinical evidence to support the eventual use of the Mobi-C cervical disc to treat patients in the United States, as well. The company said the addition of this innovative cervical non-fusion device to its U.S. product offering will position LDR for continued growth and success in the artificial cervical disc market.
The controlled mobility of the Mobi-C polyethylene insert is designed to accommodate the segmental instantaneous axes of rotation, thereby eliminating the need for invasive vertebral anchorage such as screws or keels. System instrumentation is designed to facilitate the straight forward insertion of the device with little disruption to the cervical spine, according to the release.