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LDR receives commercial sale, distribution approval for cervical disc

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LDR announced it has received FDA approval allowing the commercial sale and distribution of its Mobi-C Cervical Disc for one-level indications in the United States.

The Mobi-C is a cobalt-chromium alloy and polyethylene, mobile-bearing prosthesis specifically designed as a bone-sparing, cervical intervertebral disc replacement. According to a press release, Mobi-C offers a simplified surgical technique as compared to other commercially available devices.

“We are pleased that the FDA, after an intensive review of our Pre-Market Application, has determined that Mobi-C is safe and effective for one-level cervical disc replacement in the United States,” Christophe Lavigne, president and chief executive officer of LDR, stated. “The data from our study represents the latest Level 1 evidence supporting cervical disc replacement as an attractive treatment alternative to anterior cervical discectomy fusion for indicated patients. This approval is validation that LDR continues to introduce innovative and exclusive spine technologies designed to improve patient care.”