LDR Launches PMA Process with 2-year Patient Follow-up
AUSTIN, Texas–(BUSINESS WIRE)–LDR, a privately held company with innovative spinal implants for both non-fusion and fusion applications, reached the critical 24-month follow-up phase for the one-level IDE study on its second generation Mobi-C® cervical artificial disc. LDR is the first and currently the only company to have completed enrollment for a concurrent one-level and two-level cervical artificial disc replacement study. LDR completed 1-Level enrollment in October 2007 and 2-Level enrollment in March 2008. The 24-month follow-up phase of the two-level arm of the study is slated to be completed in March 2010.
The product was first introduced outside the U.S. in November 2004 and has now been used to treat over 7,500 patients worldwide, including those involved in this 2-arm IDE study. The controlled mobility of the Mobi-C’s insert is designed to restore and respect the instantaneous axes of rotation for a return to physiological mobility of the intervertebral disc and the cervical spine. This innovative mobile bearing design reduces the stresses on the bone-implant interface, eliminating the need for invasive vertebral anchorage such as screws or keels and allowing for multi-level use.
Christophe Lavigne, president and CEO of LDR says, “Completion of the 24-month follow-up phase of our one-level study represents another giant milestone for our company that will bring us closer to our goal of becoming the first and only metal-on-polyethylene one-level and two-level cervical disc to obtain FDA approval. We believe that the unique benefits of Mobi-C will establish it as the gold standard for cervical disc arthroplasty in the United States as it is outside the U.S. We are proud to have achieved this milestone at the same time that we are experiencing tremendous success with our VerteBRIDGE™ plating technology in the zero-profile ROI-A™ lumbar and ROI-C™ cervical cages. We are looking forward to a continued focus on bringing innovative products to our surgeon customers.”
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
Caution: 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.
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