LDR has secured an approval letter from the US Food and Drug Administration (FDA) for its low-profile cervical intervertebral disc.
The Mobi-C disc, which is a metal and polyethylene mobile bearing prosthesis, is a cervical implant designed to treat two adjacent levels of damaged discs.
Greater Baltimore Medical Center neurosciences neurosurgery chief and director Reginald Davis said, "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."
LDR president and CEO Christophe Lavigne said based on the 600 patient-based IDE clinical trial data provided in the premarket approval application, the FDA has approved Mobi-C.
"We are confident that we can efficiently complete the remaining requirements inherent in the full approval process and we anticipate commercial U.S. availability of Mobi-C in 2013," Lavigne added.
"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."