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LDR completes follow-up on a two-level cervical artificial disc IDE study
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LDR announced completion of the 24-month follow-up phase of its two-level IDE study on the Mobi-C cervical artificial disc. Having previously finalized the 24-month follow-up phase of the one-level study earlier this year, LDR is now the first company to fully enroll and reach 2-year follow-up on a concurrent one-level and two-level cervical artificial disc replacement study, according to a press release.
LDR stated it completed one-level enrollment in October 2007 and two-level enrollment in March 2008. The Mobi-C cervical artificial disc was first introduced outside the United States. in November 2004 and has now been used to treat over 8,000 patients worldwide, including those involved in this two-arm IDE study.
The Mobi-C design philosophy of controlled mobility respects the instantaneous axes of rotation for a return to physiological mobility of the treated level, the company stated in the press release. This innovative mobile bearing is designed to reduce the transmission of stresses to the bone-implant interface, minimizing the need for invasive anchoring features such as screws or keels. Free of this invasive fixation, the Mobi-C could become an excellent option for treating two consecutive levels.
Christophe Lavigne, president and CEO of LDR said, “We are the first company to have completed 24-month follow-up for both the one-level and two-level studies, and are now poised to be the first in the U.S. market with two-level approval for a cervical artificial disc. LDR is positioned to provide the best technology on the market for cervical disc arthroplasty. We strongly believe that surgeons will select a single product that addresses their need to treat both one-level and two-level patient indications.”
Hyun W. Bae, MD, a board-certified orthopaedic surgeon at The Spine Institute in Santa Monica, California, emphasized, “I was excited to participate in LDR’s two-level IDE study. I found the Mobi-C system easy to use, and have seen impressive clinical results. Since about half of my patients present with two-level cervical disease, it would be ideal to have a treatment option with both the flexibility and FDA approval to treat two-level indications.”
Lavigne stated in the press release that the company anticipates Mobi-C will be approved by the FDA in 2011.