AUSTIN, Texas–(BUSINESS WIRE)–LDR, a privately held medical device company offering innovative spinal implants for both non-fusion and fusion applications, announced the March 11 submission of its two-level Mobi-C cervical artificial disc PMA to the FDA. LDR is one of only two companies to have completed a two-level randomized IDE trial with two-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 five-year, 600-patient, two-arm IDE study and an investment of over $25 million,” said Christophe Lavigne, President and CEO of LDR. Mr. Lavigne adds, “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.”
“Achieving the Mobi-C submission milestones after having realized 77% growth in the U.S. 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.”
Dr. Reginald Davis, Chief of Neurosurgery and Director of Neurosciences at the Greater Baltimore Medical Center, said, “I am very encouraged by the clinical results of my two-level Mobi-C patients from the study, and I am increasingly confident in cervical artificial disc as an attractive treatment option for indicated patients. Given the prevalence of two-level pathology and the importance of medical evidence in the clinical decision making process, Mobi-C FDA approval for both single and two-level use could substantially transform the cervical treatment landscape.”
Founded in 2000 in Troyes, France and currently headquartered in Austin, Texas, LDR has experienced rapid growth through product portfolio expansion and an increasingly global presence. Mr. Lavigne continues, “Achieving the Mobi-C submission milestones after having realized 77% growth in the U.S. 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. Dr. Pierce Nunley, spine surgeon at the Spine Institute of Louisiana comments, “Participating in this study has convinced me of the viability and benefits of the Mobi-C technology. More specifically, the controlled motion provided by its mobile bearing platform has proved to be suitable for not only single, but two-level cervical arthroplasty as well.”
The Mobi-C metal on polyethylene disc is 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. Avoiding such violation of the adjacent vertebral bodies may be a key benefit when treating two levels.
LDR works closely with surgeons to develop unique implantable spine devices and instrumentation designed to support the clinical goals of surgery while making procedures easier to perform. More information is located at www.ldrholding.com.
Caution: Mobi-C is not available for sale in the United States and is limited to Investigational Use Only in the U.S.