Trabecular Metal Material Spine Overview. Page 1 of 6

Transcription

1 Trabecular Metal Material Spine Overview Page 1 of 6

2 What is Trabecular Metal Material? Trabecular Metal Material, exclusive to Zimmer, is a porous material structurally similar to cancellous bone. This material, made of porous tantalum using a proprietary process, creates an osteoconductive scaffold that helps facilitate vascularization and bone ingrowth. 1 Micro-textured surface Structure similar to cancellous bone Boney in-growth through the Trabecular Metal Material Experience Zimmer s transformational technology designed for boney ingrowth and three-dimensional fusion: Trabecular Metal Material is the feel of confidence. Page 2 of 6

3 Trabecular Metal Material The Feel of Confidence Greater Confidence Trabecular Metal Material s exclusive technology provides greater confidence in achieving bone ingrowth and bridging. Due to its high coefficient of friction, Trabecular Metal Material delivers tactile stability from the start. Bone Growth Requires Blood Flow Whereas traditional non-porous materials limit blood flow around and through the implant, the porous tantalum composition of Trabecular Metal Material allows the ingress of nutrients shown to facilitate bone viability. Trabecular Metal Implant wicking blood during implantation No products match the visual porosity of Trabecular Metal Material; the very moment it is placed, surgeons comment that it s instantly like blood through a sponge. Blood flows through porous structure Traditional Material Traditional Material with textured surface Trabecular Metal Material Three-dimensional fusion No boney on-growth or in-growth No boney in-growth, and boney on-growth on textured surface only Boney in-growth through the device Page 3 of 6

4 Trabecular Metal Material Explant Analysis Analysis of Trabecular Metal Material Cervical Fusion Device explant 28 months post op 2 demonstrates boney in-growth through the device Axial View Posterior View Trabecular Metal Material was specifically designed to be a highly connected network of consistently shaped, intentionally sized pores that support vascularization and allow bone remodeling and ingrowth in three dimensions 3,4 Magnified (100x) histological image showing bone growth into the porous Trabecular Metal Material structure Magnified (100x) histological image showing bone growth up to the surface of the Trabecular Metal Material structure Pink/Purple = Bone Orange/Yellow = Fibrous Tissue Black = Trabecular Metal Material Trabecular Metal Implants are some of the most clinically successful products, with over 15 years of use in a wide variety of clinical applications. Page 4 of 6

5 Trabecular Metal Material Three-Dimensional Fusion Imaging Surgeons who use Trabecular Metal Material are confident in their ability to assess fusion through routine imaging modalities. X-Ray Evaluating bone-device interface Clinical Significance: Sentinel signs, a lack of radiolucent lines at the implant-endplate interface, and appearance of the stability of anterior or posterior hardware give evidence of fusion Flexion/extension films may be used to evaluate angular and translational motion of the segments to be fused X-Ray MRI Scan Evaluating soft tissues around the device Clinical Significance: Trabecular Metal Material causes the least artifact and image distortion of any orthopedic metal MRI CT Scan Evaluating bone-implant interface Clinical Significance: Coronal, sagittal, and axial reformations suggested; coronal and sagittal views have less artifact than axial Metal artifact reduction software can be used to reduce image scatter CT Page 5 of 6

6 Disclaimer: This documentation is intended exclusively for physicians and is not intended for laypersons. Information on the products and procedures contained in this document is of a general nature and does not represent and does not constitute medical advice or recommendations. Because this information does not purport to constitute any diagnostic or therapeutic statement with regard to any individual medical case, each patient must be examined and advised individually, and this document does not replace the need for such examination and/or advice in whole or in part. Please refer to the package inserts for important product information, including, but not limited to, indications, contraindications, warnings, precautions and adverse effects. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Please see the product Instructions for Use for a complete listing of the indications, contraindications, warnings, precautions and adverse effects. Printed in U.S.A. Subject to change without notice. 1 In the United States, the TM Ardis, TM-S and TM-400 Systems are indicated for use with autogenous bone graft as an intervertebral body fusion device at one (TM-S) or one or two contiguous levels (TM Ardis System, TM-400) with supplemental fixation. 2 Independent data provided by Medical Device Research. Patient underwent revision ACDF surgery to address radicular pain and mechanical neck pain. 3 Bobyn JD, Hacking SA, Chan SP, et al. Characterization of new porous tantalum biomaterial for reconstructive orthopaedics. Scientific Exhibition: 66th Annual Meeting of the American Academy of Orthopaedic Surgeons; 1999; Anaheim, CA. 4 Karageorgiou V, Kaplan D. Porosity of biomaterial scaffolds and osteogenesis. Biomaterials. 2005;26: Contact your Zimmer Spine representative or visit us at Manufactured by: Zimmer TMT 10 Pomeroy Road Parsippany, NJ Distributed by: Zimmer Spine 7375 Bush Lake Road Minneapolis, MN zimmerspine.com ZS-SA0861 Rev. A ( ) (851S ) 2014 Zimmer Spine, Inc. Page 6 of 6