LDR has received a letter of approval from the US Food and Drug Administration (FDA) for commercial sale and distribution of its Mobi-C Cervical Disc (Mobi-C), for one-level indications in the US.
The Mobi-C is designed for cervical disc replacement to restore segmental motion and disc height. It is claimed to be the first mobile-bearing, bone-sparing cervical disc approved in the US market.
Mobi-C is a cobalt chromium alloy and polyethylene, mobile-bearing prosthesis specifically designed as a bone-sparing, cervical intervertebral disc replacement.
Compared to other commercially available devices, Mobi-C offers a simplified surgical technique.
The data from one-level arm of the investigational device exemption (IDE) trial demonstrated to be a better treatment alternative to anterior cervical discectomy fusion (ACDF).
LDR president and CEO Christophe Lavigne noted the company is pleased that the FDA, after an intensive review of its Pre-Market Application (PMA), has determined that Mobi-C is safe and effective for one-level cervical disc replacement in the US.
"This approval is validation that LDR continues to introduce innovative and exclusive spine technologies designed to improve patient care," Lavigne added.
LDR also received an approvable letter for Mobi-C for two-level indications in October 2012. The two-level PMA is continuing through the review process with the FDA.