FDA approval for the Mobi-C disc at one level

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LDR has announced that it can now sell its Mobi-C disc for one-level indications as it has received FDA approval. It reports that the device is a cobalt chromium alloy and polyethylene, mobile-bearing prosthesis and offers a simplified surgical technique as compared to other commercially available devices.

According to a company press release, the one-level arm of the investigational device exemption (IDE) trial of Mobi-C demonstrated non-inferiority in overall trial success compared with anterior cervical discectomy and fusion (ACDF). The difference between Mobi-C’s overall success rate of 73.7% and ACDF’s rate of 65.3% represented statistical non-inferiority (p=0.0021). The press release added that other findings, at the 24-month endpoint, included:

  • The rate of secondary surgery at the index level for Mobi-C was 1.2% vs. 6.2% for ACD
  • The percentage of subjects who reported negative radiographic changes from baseline in adjacent segments was at the inferior adjacent level, 7.7% of Mobi-C patients vs. 21.0% of ACDF patients; and at the superior adjacent level, 14.6% of Mobi-C patients vs. 25.0% of ACDF patients
  • Mean return to work time was 29.3 days for Mobi-C vs. 36.8 days for ACDF.
  • Mobi-C is a safe and effective surgical option at one-level in the cervical spine from C3C7 for indicated patients.

“The data from the one-level Mobi-C trial adds to the extensive library of evidence supporting cervical disc replacement as an attractive alternative to anterior cervical fusion,” said Michael Hisey of the Texas Back Institute, Plano, USA. “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.”
 

 

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