Physician Resources
Newly Available, Newly Approved
Am J Orthop. 2008 July;37(7):381
Vertebral Compression Fracture System
| DePuy Spine, Inc. has announced the worldwide launch of the CONFIDENCE SPINAL CEMENT SYSTEM™, a novel treatment for vertebral compression fractures. The CONFIDENCE System consists of a proprietary hydraulic-based delivery system that provides precise placement of a specially formulated high-viscosity polymethylmethacrylate (PMMA) bone cement directly into vertebral bodies to stabilize fractures and to potentially reduce pain. The company wishes to note that the CONFIDENCE Spinal Cement System is easy to use and has a very short mixing time. The dough-like consistency of the CONFIDENCE High Viscosity Cement provides a controlled, more even fill than that of low-viscosity cement.1 CONFIDENCE achieves high viscosity immediately after mixing and stays at a constant high viscosity for 9 minutes, allowing for optimal working time. The high-viscosity properties of the CONFIDENCE Cement are designed to allow for interdigitation, preserving the remaining trabecular structure of the vertebral body. The unique hydraulic-based delivery system allows the high-viscosity cement to flow easily through a long, thin introducer needle and into the fracture site. The system also allows delivery and control outside the fluoro field, reducing the surgeon’s exposure to radiation. For more information about the CONFIDENCE System, DePuy Spine
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Anterior Lumbar Partial Vertebral Body Replacement Device
| LDR has begun to market its ROI-A™ partial vertebral body replacement device following 510(k) clearance from the United States Food and Drug Administration. 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 composed 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. For more information, LDR |