Dual level cervical disk implant gets FDA approval

AUSTIN, TX – LDR Medical has received an approval letter from the US Food and Drug Administration (FDA) for its Mobi-C Cervical Disc. The disc is a metal and polyethylene mobile bearing prosthesis designed as a low-profile cervical intervertebral disc replacement for both one- and two-level applications.

“We are pleased that the FDA, after an intensive review of our submission for Mobi-C, has determined it to be approvable based on the strength of the data provided in the premarket approval application (PMA). We are confident that we can efficiently complete the remaining requirements inherent in the full approval process and we anticipate commercial US availability of Mobi-C in 2013,” said Christopher Lavigne, president and CEO, LDR Medical.

“Given the high incidence of two-level cervical disease, we are proud that Mobi-C may become the first cervical disc available to treat patients on-label that suffer from two-level pathology. 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 prospective study performed comparing Mobi-C to ACDF,” Mr Lavigne added.