AUSTIN, Texas, July 26 /PRNewswire/ -- LDR Spine, a total spine solution company, today announced that it has obtained 510(k) clearance from the United States Food and Drug Administration to market two more of its fusion spine products in the U.S. LDR Spine will begin marketing and selling the MC+(R) and ROI partial vertebral body replacement systems (PVBRs) to U.S. surgeons for implantation in commonly used fusion techniques for the treatment of degenerative spine disease.
The clearance to market these products in the United States further positions LDR Spine to implement on its stated plans to provide the U.S. surgeon community with innovative fusion and non-fusion product lines. LDR Spine’s Easyspine(R) posterior osteosynthesis system and its BF+(R) complementary synthetic bone substitute obtained FDA 510(k) clearance in Q1 2005.
“Gaining FDA approval for MC+(R) and ROI is a strong addition to our existing product portfolio and helps to complete our fusion product offerings in the U.S., which is the largest and fastest growing segment of the global musculoskeletal market,” said Steve Whitlock, president and CEO of LDR Spine. “Both systems have been well received by the surgeon community because of their simplified instrumentation and a unique design that affords a larger grafting area.”
MC+(R) and ROI were designed by a dedicated team of neurological and orthopedic surgeons to address unmet or underserved needs. Both products feature a unique design that provides surgeons with a large grafting area, an important feature that enables placement of the implants’ weight-bearing surfaces on the strongest areas of the vertebral endplate. MC+(R) and ROI come individually packaged and sterilized, and offer many areas of differentiation in their design, material, instrumentation and ease-of-use.
Whitlock added, “We are the only spine company to individually package and sterilize our products. While the total joint market has long employed this approach, it is only a matter of time before all spine companies’ products are also packaged and delivered this way. LDR Spine is proud to lead the way with this safety and efficiency feature.”
Developed in France by LDR Medical with strong surgeon involvement, MC+(R) and ROI have been used successfully in over 3000 procedures to date. More information about LDR Spine products as well as surgical animations, videos and clinical case examples are available at http://www.ldrspine.com .
About LDR Spine
LDR Spine supplies U.S. surgeons with innovative spinal solutions in partnership with LDR Medical of Troyes, France. LDR Spine works closely with surgeons to develop implantable systems and instrumentation that restore optimum stability and mobility to patients, and make spine surgery more reproducible and easier to perform. More information is located at http://www.ldrspine.com .
FOR MORE INFORMATION: PR Contact: Debbie Herrington, Hill & Knowlton 512-331-0547 (direct) 512-372-6650 (main) debbie.herrington@hillandknowlton.com Company Contact: Jerry DeVries, LDR Spine 512-344-3301 jerrydevries@ldrspine.com
LDR Spine
CONTACT: Debbie Herrington of Hill & Knowlton, direct, +1-512-331-0547, ormain, +1-512-372-6650, or debbie.herrington@hillandknowlton.com , for LDRSpine; or Jerry DeVries of LDR Spine, +1-512-344-3301, orjerrydevries@ldrspine.com
Web site: http://www.ldrspine.com/