Integra ® Accell Connexus® Accell Total Bone Matrix® (TBM) Limit uncertainty with an advanced demineralized bone matrix - powered by Accell® Technology Integra’s patented* Accell® process converts particulate DBM into a dispersed form, which offers early accessibility to naturally occurring inductive bone proteins1 Integra® Accell Connexus® / Accell TBM® Integra® Accell Connexus® Demineralized Bone Matrix and Accell Total Bone Matrix® (TBM) Accell Connexus Accell TBM Accell Connexus is moldable and easy to pack into virtually any defect shape Accell TBM is available in a variety of sizes and is ready to use Features • Accell Bone Matrix • Patented*, dispersed form of DBM • Due to increased surface area, provides early access to naturally occurring bone proteins contained in DBM1 • Integra processed DBM with proven osteoinductive potential (using a validated assay)2 • Poloxamer Reverse Phase Medium Carrier • Thickens at body temperature • Resists irrigation • Biocompatible and inert • Safety through e-beam sterilization • Electron beam sterilized as the last step in the manufacturing process Features • Accell Bone Matrix • Patented*, dispersed form of DBM • Due to increased surface area, provides early access to naturally occurring bone proteins contained in DBM1 • Integra processed DBM with proven osteoinductive potential (using a validated assay)2 • Pre-formed, 100% DBM • Easily cut to fit any size or shape defect • Osteoconductive framework • Safety through e-beam sterilization • Electron beam sterilized as the last step in the manufacturing process The Accell® Advantage — What’s the Difference? Patented* ABM and particulate DBM combined Particulate DBM 2 Standard Process Accell Process 2 ABM Ground Cortical Bone 30x Standard particulate DBM is dense and requires more time to break down. Until these dense particles break down, access to naturally occurring bone proteins is limited. 2 Combined to Form Accell Products 30x The combination of ABM and particulate DBM provides for both immediate and sustained accessibility to naturally occurring bone proteins which are important for osteogenesis.1 30x Accell Bone Matrix (ABM) is an openstructured, dispersed form of DBM, which provides accessibility to naturally occurring bone proteins without the need to be broken down. As a result this creates a favorable environment for the formation of bone. What is Our Patented* Accell® Bone Matrix? Particulate DBM Patented* ABM Particulate DBM is formed by removing the mineral component of ground cortical bone. Accell Bone Matrix is transformed from particulate DBM using the patented** Accell Process. At higher magnification, DBM can be seen as a dense matrix. At higher magnification, ABM can be seen as a white, highly porous matrix. Particulate DBM consists of a highly dense matrix of Type-I Collagen and naturally occurring bone proteins, with limited accessibility. ABM consists of an open pore structure with high surface area. The resultant scaffold provides accessibility to bone proteins, which creates a favorable environment for the formation of bone. Graphically shown, wavy lines represent Type-I Collagen. The blue and red symbols denote naturally occurring bone proteins in bone. Osteoinductive Potential- In Vitro Measurement1 Accell® Bone Matrix’s increased surface area provides access to natural bone proteins. The higher surface area and more open pore structure of ABM provides accessibility to the bone proteins, without the need to be broken down. This analysis shows that while ABM provided early accessibility of naturally occurring bone proteins, particulate DBM provides for accessibility of naturally occurring bone protein at later time points. Integra’s Accell family of products combine the virtues of ABM and DBM in one unique product. Bone Protein Natural bone protein content of ABM and particulate DBM was measured in vitro over time using an Enzyme Linked Immunosorbent Assay (ELISA). The results are shown graphically and indicate that bone protein was detectable in a saline solution containing ABM at earlier time points compared to that of particulate DBM. Accell® Bone Matrix (ABM) vs. Demineralized Bone Matrix (DBM) ABM DBM Time Integra® Accell Connexus® / Accell TBM® Accell Connexus® Demineralized Bone Matrix Accell Total Bone Matrix® Reference Description Size Reference Description Size 02-3000-005 02-3000-010 02-3000-025 02-3000-050 02-3000-100 Putty (syringe) Putty (syringe) Putty (syringe) Putty (syringe) Putty (syringe) 0.5cc 1cc 2.5cc 5cc 10cc 02-4000-520 02-4000-550 02-4000-760 Matrix (strip) Matrix (square) Matrix (round) 5x2x0.5cm 5x5x0.5cm 7x0.6cm References 1. Khaliq S, Lollis R, Bell D, Oliver R, Walsh WR, and Ingram R, Evaluation of a Next Generation DBM Putty in a Posterlateral Spinal Fusion Model, (2009) Integra LifeSciences Corporation. 2. Data on file Indications for Use Accell Connexus® Accell Connexus is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Connexus is indicated for use as a bone graft extender in the spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. Accell TBM® Accell TBM is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell TBM is indicated for use as a bone graft extender in the spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. Warnings and Precautions Accell Connexus® Accell Connexus is sterile during the stated shelf life in an unopened and undamaged package. The product must be used prior to the expiration date. Do not use if the packaging has been damaged and/or the product has been contaminated. In the event of contamination, discard the product. Damaged prackaging should be returned to Integra LifeSciences. Appropriate placement and/or fixation are critical factors in the avoidance of potentially adverse effects. As with all biological products, the tissue in Accell Connexus has the potential to transmit infectious agents despite processing treatments, extensive donor screening, tissue selection and laboratory tests. To date, there have been no reports of experimental or clinical viral seroconversion using demineralized bone powder. As with any surgical procedure, the possibility of infection exists. Use caution when filling a closed defect. Resistance during extrusion may be an indication of over pressurization. Excessive pressurization of the device may lead to extrusion beyond the site of intended application, damage to surrounding tissues and could result in fat embolization and/or embolization of the material into the bloodstream. When introducing Accell Connexus, it must be taken care to avoid excessive compaction. Overfilling the implantation site must be avoided to achieve a tension-free closure of the wound. Although the production technique is designed to eliminate antigenic properties of the product, the possibility of such a reaction is present. Adverse outcomes potentially attributable to the product must be reported promptly to the manufacturer. If any dissatisfaction with the product performance or packaging occurs, notify Integra LifeSciences immediately and promptly return product and/or packaging. Accell TBM® Accell TBM is sterile during the stated shelf life in an unopened and undamaged package. The product must be used prior to the expiration date. Do not use if the packaging has been damaged and/or the product has been contaminated. In the event of contamination, discard the product. Appropriate placement and/or fixation are critical factors in the avoidance of potentially adverse effects. As with all biological products, the tissue in Accell TBM has the potential to transmit infectious agents despite processing treatments, extensive donor screening, tissue selection and laboratory tests. To date, there have been no reports of experimental or clinical viral seroconversion using demineralized bone powder. As with any surgical procedure, the possibility of infection exists. Although the production technique is designed to eliminate antigenic properties of the product, the possibility of such a reaction is present. Adverse outcomes potentially attributable to the product must be reported promptly to the manufacturer. When introducing Accell TBM, it must be taken care to avoid excessive compaction. Overfilling the implantation site must be avoided to achieve a tension-free closure of the wound. For further information refer to each product’s package insert. * U.S. Patent Nos. 7,132,110; 7,811,608 ** U.S. Patent No. 7,132,110 For more information or to place an order, please contact: Integra 2 Goodyear Suite A, Irvine, CA 92618 800-550-7155 USA 800-471-3248 fax integralife.com n n Accell, Accell Connexus, Accell Total Bone Matrix, Accell TBM, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. ©2012 Integra LifeSciences Corporation. All rights reserved. Printed in the USA. 2.5k 0024411-1
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