AUSTIN, Texas--(BUSINESS WIRE)--LDR, a total spine solution company, announced today that it has begun to market its ROI-A™ partial vertebral body replacement device following 510(k) clearance from the United States Food and Drug Administration in April. The ROI-A™ system incorporates the innovative verteBRIDGE™ anchoring technology.
The ROI-A™ is a stand-alone implant system with zero profile, self-locking anchoring plates designed for initial and long-term stability. The surgical technique is a direct anterior approach, with the curved anchoring plates inserted along the sagittal plane thus requiring no additional exposure to the vertebral bodies.
The ROI-A™ device is made of PEEK-Optima® for biocompatibility and radiolucency along with Tantalum markers for verification of implant positioning. The system is comprised of multiple footprint sizes, lordotic angles and heights for optimized fit per anatomical requirements. An innovative inserter holds the implant, protecting vascular structures and guiding the anchoring plates during insertion.
Christophe Lavigne, CEO of LDR, comments, “The entry of the ROI-A™ implant into the U.S. market represents a huge step for us in continuing to provide innovative, surgeon-friendly solutions for varied spinal pathologies. This is really an exciting innovation and we will soon be introducing other products that incorporate our verteBRIDGE™ anchoring technology.”
Since launching the ROI-A™ more than 75 procedures have been performed with extremely positive feedback from the surgeons.
Dr. Charles Gordon, Gordon Spine Associates, Tyler, Texas, highlights “Overall, the innovative anchoring technology combined with well-designed instrumentation and the straight anterior approach provides a very effective solution for lumbar partial vertebral body replacement.”
Dr. Michael Hisey, Texas Back Institute, Denton, Texas, adds “The instrument set is simple and easy to use. Implant placement and anchoring plate insertion occurs inside the inserter, protecting the major vascular structures during the procedure.”
Dr. Vincent Leone, New York Orthopedic and Spine Services, Great Neck, New York, comments “The curved anchoring plates are an innovative feature allowing me to work very effectively through a small incision and still have easy placement and insertion of the implant and anchoring plates.”
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. Additional information on the verteBRIDGE technology can be found at www.vertebridge.com.
Contact:
LDR James Burrows, 512-344-3307 VP of Product Commercialization jamesburrows@ldrspine.com
Source: LDR
