LDR receives approvable letter from FDA for two-level Mobi-C Cervical Disc

103

LDR has announced that it has received an approvable letter from the US Food and Drug Administration (FDA) for its Mobi-C Cervical Disc. Mobi-C is a metal and polyethylene mobile bearing prosthesis specifically 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. 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 Christophe Lavigne, president and CEO of LDR. “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.”


FDA has determined that Mobi-C is approvable for two-level indications, subject to the satisfaction of all applicable requirements of the Quality System Regulations (21 CFR Part 820), as well as finalisation of the labeling and post-approval study. FDA will issue an approval order, allowing commercial sale and distribution, after said requirements have been reviewed and determined to be acceptable.


“The Mobi-C two-level study data, as presented at the North American Spine Society (NASS) 2012 Annual Meeting, demonstrate the potential to treat two-level cervical disease using the Mobi-C Cervical Disc as an alternative to ACDF,” said Reginald Davis, chief of Neurosurgery and Director of Neurosciences at the Greater Baltimore Medical Center. “The anticipated full approval of Mobi-C will give surgeons a valuable treatment option for patients with two-level disease, where there is no approved motion preserving option.”

(Visited 10 times, 1 visits today)