LDR Receives FDA Approval for the Mobi-C Cervical Disc for One-Level Use (press release)
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 one-level indications in the United States.
“I am very pleased now that Mobi-C is approved for one-level indications, as I will have the opportunity to offer my patients a state-of-the-art treatment option that will address their symptoms while providing the potential to maintain normal spinal motion.”
“We are pleased that the FDA, after an intensive review of our Pre-Market Application (PMA), has determined that Mobi-C is safe and effective for one-level cervical disc replacement in the United States,” said Christophe Lavigne, President and CEO of LDR. “The data from our study represents the latest Level I evidence supporting cervical disc replacement as an attractive treatment alternative to anterior cervical discectomy fusion (ACDF) for indicated patients. This a...
