LDR is the First to Announce Completion of Two-year Follow-Up on a Two-Level Cervical Artificial Disc IDE Study

LDR prepares PMA submission for FDA review of the Mobi-C® cervical artificial disc

AUSTIN, Texas--(HSMN NewsFeed)--LDR, a privately held company with innovative spinal implants for non-fusion and fusion applications, 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 two-year follow-up on a concurrent one-level and two-level cervical artificial disc replacement study. LDR 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 U.S. in November 2004 and has now been used to treat over 8,000 patients worldwide, including those involved in this 2-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. 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.

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