LDR prepares PMA submission for FDA review of the Mobi-C® cervical artificial disc
AUSTIN, Texas (April 20, 2010) – 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.
Christophe Lavigne, President and CEO of LDR says, “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 US 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.”
Dr. Hyun W. Bae, a board-certified orthopaedic surgeon at The Spine Institute in Santa Monica, California, emphasizes, “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.”
Mr. Lavigne continues, “We are excited about the future as we enter into the next phase of the PMA process. With the anticipated Mobi-C approval in 2011 and the strong success we continue to enjoy with our ROI-C™ cervical cage featuring VerteBRIDGE™ plating technology, we are positioned to provide compelling mini-open, zero-profile solutions for both fusion and motion preservation in the cervical market.”
LDR works closely with surgeons to develop implantable spine systems and instrumentation that restore optimum stability and mobility to patients and to make spine surgery more reproducible and easier to perform. More information is located at www.ldrholding.com.
For More Information:
Dana Kolflat, Director-Marketing, LDR
Mobi-C is an Investigational device in the U.S. and is limited by U.S. law to investigational use. Mobi-C is not available for use in the United States.
©2010 LDR Holding Corporation, All Rights Reserved