LDR submits premarket approval to the FDA for Mobi-C cervical artificial disc

126

LDR announced the January 14th submission of its single-level Mobi-C cervical artificial disc for premarket approval to the FDA. Mobi-C polyethylene insert is designed to accommodate the segmental instantaneous axes of rotation, thereby eliminating the need for invasive vertebral anchorage such as screws or keels. The System instrumentation is designed to facilitate the straight forward insertion of the device with little disruption to the cervical spine.

“It is extremely satisfying to submit the study results to the FDA and we are very pleased with the preliminary study outcomes,” said Christophe Lavigne, president and CEO of LDR. Michael Hisey, spine surgeon at the Texas Back Institute in Plano, Texas, said, “I feel very fortunate to have been able to participate in the IDE study, and I look forward to having the Mobi-C cervical disc as an approved device option in the future. I am happy with the clinical results of the patients who received the Mobi-C at our center and I feel that cervical disc replacement can be an excellent treatment option.”

 

Since its introduction in 2004, the Mobi-C cervical disc has been implanted in over 10,000 patients outside the USA. The IDE study results represent additional clinical evidence to support the eventual use of the Mobi-C cervical disc to treat patients in the United States as well.

 

Gregory Hoffman, spine surgeon at SpineONE and president of the Fort Wayne Orthopaedic Society, agrees, “The encouraging clinical results of the Mobi-C IDE study that I have observed will add significantly to the body of evidence supporting cervical spine arthroplasty. There is justified optimism regarding the potential benefits of cervical artificial discs and for Mobi-C in particular.” The study data will be submitted by IDE investigators for publication and for presentation at future scientific conferences, including the upcoming ISASS meeting in Las Vegas in April.

Mobi-C is not available for use in the United States.

(Visited 21 times, 1 visits today)