AUSTIN, TX (August 28, 2013) – LDR, a privately held medical device company offering exclusive spinal implant technologies for both non-fusion and fusion applications, today announced that it has received a letter of approval from the U.S. Food and Drug Administration (FDA) allowing the commercial sale and distribution of the Mobi-C Cervical Disc (Mobi-C) for two-level indications, making it the first and only cervical disc in the United States approved to treat more than one level of the cervical spine. LDR previously received a letter of approval on August 7, 2013 from the FDA allowing the commercial sale and distribution of the Mobi-C for one-level use.
“We are very pleased that the FDA, after an intensive review of our submissions, has determined that Mobi-C is safe and effective for both one and two-level indications in the United States, and superior to fusion for two-level cervical disc replacement, based on the results of our prospective, concurrently controlled and randomized, multi-center clinical trials,” said Christophe Lavigne, president and CEO of LDR. “We are proud that LDR is first to offer an on-label, arthroplasty solution for the significant number of patients suffering from two-level cervical disc disease. It is very gratifying to know that spine surgeons can now offer this new, evidence-based treatment option to their two-level surgical candidates.”
Mobi-C is a cobalt chromium alloy and polyethylene, mobile-bearing prosthesis specifically designed as a bone-sparing, cervical intervertebral disc replacement for both one and two-level indications. In addition to the unique mobile-bearing feature, Mobi-C offers a simplified surgical technique as compared to other, commercially available devices, all of which are approved for one-level use only.
