New Replacement Device for Lumbar Spine Market Ready
LDR Holdings, a company that specializes in the development of tools for spinal surgery, announced the FDA approval for its new ROI-A Anterior Lumbar Partial Vertebral Body Replacement Device. Marketing efforts have commenced.
The ROI-A is manufactured from PEEK-Optima, to ensure device biocompatibility. Identification of the device is completed because of the radiolucency of the material, as well as the incorporation of Tantalum markers. The new ROI-A system incorporates the company’s verteBRIDGE technology used for the anchoring of devices.
This is a stand-alone tool with a zero profile. The system includes anchoring plates which are self-locking; these provide both initial and long-term stability of the device.
The surgical technique for placement of the device is a direct anterior effort. The curved plates for anchoring are secured via the sagittal plane. This approach does not require any additional exposure of the vertebrae.
June 16, 2008 Related topics: Product Approval & Certification, Orthopedic