LDR Spine™ Receives FDA 510(k) Clearance for Easyspine® Spinal System and BF+® Bone Substitute
LDR Products to Debut During Week of AAOS Meeting in Washington, D.C.
Austin, TX - February 22, 2005
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 of its fusion spine products in the U.S. LDR Spine will formally introduce U.S. surgeons to its product line during the week of the American Academy of Orthopedic Surgeons meeting in Washington, DC.
The FDA granted clearance for the company to market the Easyspine posterior osteosynthesis system and the BF+ complementary synthetic bone substitute comprised of beta tri-calcium phosphate featuring outstanding biocompatibility characteristics.
The clearance to market these products positions LDR Spine to execute the first phase of its plans to introduce an innovative product line of fusion and non-fusion spinal systems to U.S. surgeons in the largest and fastest growing segment of the musculoskeletal global market.
“Obtaining FDA 510(k) clearance to market the Easyspine System and the BF+ Synthetic Bone Substitute allows us to deliver a total spine solution that potentially will improve surgical efficiency for the surgeon and the operating room staff, enhance sterility assurance and simplify product traceability from the manufacturer to the patient,” said Steve Whitlock, President and CEO of LDR Spine. “We are excited by the success these products have experienced in Europe and are encouraged by the enthusiastic response we are getting from both surgeons and spine device distributors regarding all of our spinal product offerings.”
Developed in France by LDR Médical with strong surgeon involvement, Easyspine has been used successfully in over 2,200 procedures to date. Its unique patent-pending pedicle screw design, with integrated multi-axial capability, provides flat-on-flat screw to rod purchase, and can achieve a variety of stiffnesses by accommodating rods of different thicknesses. This design approach provides many technical advantages and creates a system that offers the surgeon increased intraoperative flexibility while only using one-third the inventory levels of conventional fusion systems. Additionally, all LDR Spine implant products are delivered to the hospital individually packaged, labeled and sterilized, thereby reducing sterility concerns and improving product traceability - a feature no other spine company currently offers.
About LDR Spine
LDR Spine supplies U.S. surgeons with innovative spinal solutions in partnership with LDR Médical of Troyes, France. LDR Spine works closely with surgeons to develop implantable systems and instrumentation that make spine surgery reproducible, easier to perform, and restores optimum stability and mobility to patients. More information is located at
www.ldrspine.com.
Company Contact:
James Burrows, VP of Product Commercialization, LDR
(512) 344-3307
jamesburrows@ldrspine.com
Easyspine and BF+ are trademarks or registered trademarks of LDR Médical S.A.S. in the United States and foreign countries.