This article is more than 5 years old. Information may no longer be current.
LDR submits two-level cervical artificial disc PMA
Click Here to Manage Email Alerts
LDR announced that it submitted a PMA for its two-level Mobi-C cervical artificial disc to the FDA on March 11.
In a press release, LDR said it is one of two companies to have completed a two-level randomized IDE trial with 2-year follow-up, and is the first to submit its results. “Following quickly on our January single-level PMA, this two-level submission is a historic achievement for LDR. It represents the culmination of a 5-year, 600-patient, two-arm IDE study and an investment of over $25 million,” Christophe Lavigne, president and CEO of LDR, stated in the release. “We are extremely pleased with the results of both arms of the study and with the two-level data in particular. Mobi-C investigators will be presenting study results next month at the ISASS meeting in Las Vegas.”
Lavigne continuesd “Achieving the Mobi-C submission milestones after having realized 77% growth in the United States in 2010 is very exciting. The addition of Mobi-C to our growing U.S. portfolio will greatly strengthen our position both domestically and globally, providing us the critical mass necessary for long-term growth.”
The Mobi-C Cervical Artificial Disc has been used to treat more than 10,000 patients outside of the United States since 2004. It is a metal-on-polyethylene disc designed to accommodate the segmental instantaneous axes of rotation, thereby reducing the implant to bone stresses which eliminates the need for invasive vertebral anchorage such as screws or keels, according to the press release. Avoiding such violation of the adjacent vertebral bodies may be a key benefit when treating two levels, the company stated.