NEWLY AVAILABLE, NEWLY APPROVED


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
325 Paramount Drive
Raynham, MA 02767
phone (508) 880-8100
www.ConfidenceSpinalCement.com


References


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
4030 W. Braker Lane, Suite 360
Austin, TX 78759
phone (512) 344-3333
www.vertebridge.com



PEEK Rod System

DePuy Spine, Inc. has launched the EXPEDIUM™ PEEK Rod System, a load-sharing posterior instrumentation system designed to increase anterior column loading and support the interbody fusion process in the thoracolumbar spine.

EXPEDIUM PEEK rods shift compressive axial forces from the posterior elements to the interbody fusion site, more closely reproducing the normal loading characteristics of the lumbar spine. The EXPEDIUM PEEK Rod System is also said to decrease forces on the bone screw interfaces compared with more rigid metal rod constructs.

EXPEDIUM PEEK rods are made of PEEK-OPTIMA®, a biocompatible polymer of polyetheretherketone (PEEK), which, DePuy notes, provides a unique combination of strength and flexibility for load-sharing spinal instrumentation applications. The material is infused with barium sulfate, a radiopaque compound that allows surgeons to use standard x-ray technologies to visualize both the PEEK rod implants and the fusion mass site without the imaging interference associated with titanium or stainless steel rods.

EXPEDIUM PEEK rods are available in standard 5.5-mm and 6.35-mm diameters and feature round geometry, which helps reduce the construct profile compared with larger-diameter, oval-shaped PEEK rod implants. In addition, EXPEDIUM PEEK rods are compatible with the EXPEDIUM 5.5 and 6.35 and VIPER™2 Spine Systems supporting both open and minimally invasive (MIS) approaches. Surgeons now have the freedom to make intraoperative decisions regarding the use of either titanium or PEEK Rods without having to utilize 2 separate instrumentation systems.

For more information, contact

DePuy Spine Inc.
325 Paramount Drive
Raynham, MA 02767
phone (800) 227-6633
www.depuyspine.com