LDR Receives FDA Conditional Approval for Cervical Disc

November 07, 2012 | Print  |

LDR has announced it has received FDA conditional approval for its Mobi-C cervical disc, according to a news release.


LDR describes Mobi-C as 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. 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," said Christophe Lavigne, president and CEO of LDR, in the release. "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."


LDR is headquartered in Austin, Texas.


Related Articles on FDA Clearances:

CareFusion Receives FDA Clearance for Take-Apart Laparoscopic Scissors

Teleflex Receives FDA Clearance for Reusable Obturators

Thermedical Receives FDA Clearance for Ablation System

© Copyright ASC COMMUNICATIONS 2018. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.

To receive the latest hospital and health system business and legal news and analysis from Becker's Hospital Review, sign-up for the free Becker's Hospital Review E-weekly by clicking here.