Integra
®
Accell Evo3® / Accell Evo3®c
Limit uncertainty with an
advanced demineralized bone
matrix - powered by Accell®
Technology
The Accell Evo3® technology has
demonstrated both immediate
and sustained accessibility to
naturally occurring inductive
bone proteins2
Integra®
Accell Evo3® / Accell Evo3®c Integra Accell Evo3® and Evo3®c
Accell Evo3® combines patented ABM and particulate DBM
Accell® Bone Matrix x 3
Accell Evo3 contains 3 times more Accell Bone Matrix (ABM) than the previous generation of Accell
Demineralized Bone Matrix products.*
This patented, dispersed form of DBM offers significantly increased surface area, which provides access to the naturally occurring bone proteins contained in DBM.
Superior Handling
Accell Evo3 incorporates a poloxamer Reverse Phase Medium (RPM), a biocompatible carrier. This unique thermoreversible carrier allows Accell Evo3 to meet the needs of challenging surgical applications where robust handling is essential.
• At room temperature, Accell Evo3 is malleable and easily extruded from the syringe.
• At body temperature, Accell Evo3 is more viscous, resists irrigation and minimizes graft migration.
Custom, Ready to Use Syringe
The ergonomic syringe design facilitates easy handling and extrusion of the graft. The large diameter extrusion is ideal for graft placement and mixing if required. Accell Evo3 and Evo3c are ready for implantation directly from the syringe. They do not require any cumbersome or time-consuming preoperative preparation such as thawing or mixing.
Integra DBM: An Expert Approach to DBM Processing
Integra controls the processing of DBM and Accell Bone Matrix (ABM) from start to finish in its state-of-the-art facility. Each lot is tested in a validated in vitro assay to verify osteoinductive potential.1
Safety Through E-Beam Sterilization
Integra utilizes electron beam (e-beam) sterilization to ensure product sterility. Integra’s sterilization process has not been shown to impact the osteoinductive potential of DBM.1 All products are e-beam sterilized as the last step in manufacturing prior to being shipped.
Cancellous Bone
Accell Evo3c contains cancellous chips that complement the osteoconductive scaffold by providing a natural porous structure that encourages tissue and vascular ingrowth. Cancellous bone is resorbed naturally by being incorporated into new bone during the remodeling process.1
*Compared to Accell Connexus®
The Accell® Advantage — What’s the Difference?
Accell Evo3® combines patented ABM and particulate DBM
Particulate DBM
Standard
Process
1
Accell
Process
1
Patented ABM
Ground Cortical Bone
30x
1
Standard particulate DBM is dense and requires more time to break down. Until these dense particles break down, access to natural bone proteins is limited.
Combined to Form Accell Products
30x
Accell Bone Matrix (ABM) is an openstructured, dispersed form of DBM, which provides accessibility to bone
proteins without the need to be broken
down. As a result this creates a favorable
environment for the formation of bone.
30x
The combination of ABM and particulate DBM provides for both immediate and sustained accessibility to bone proteins which are important for osteogenesis.2
Clinical Evidence
Accell Evo3® in Clinical Use
6 months post surgery
65 year old female with L3-L5 stenosis and L4-L5 degenerative spondylolisthesis. Surgery involved L3-S1 decompression with L3-L5 posterior spinal fusion with local bone graft and Accell Evo3 along with
instrumented fixation. Patient was pain free at six months post surgery with radiographically evident solid intertransverse process fusion.3
10 months post surgery
53 year old male with lumbar spondylosis, lumbar central and lateral recess stenosis L4-L5 and L5-S1 with
incompetent lumbar motion segments L4-L5 and L5-S1 secondary to spondylosis and degenerative lumbar
disc disease. Surgery involved laminectomies of both sides of L4-L5 and L5-S1 for complete decompression
of the lateral recesses. Disc material was removed and replaced with interbody cages. Posterolateral intertransverse arthrodesis
was obtained by using spinal instrumentation and Accell Evo3 with local and iliac crest autograft in the
posterolateral space and lateral gutters. Ten months postoperatively, the patient was free of any residual
symptoms and has returned to daily activities. Radiographs showed solid fusion at both operated levels.4 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 Measurement2
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.
Accell Evo3 combines 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
Evolution of DBM to Accell Evo3®
1st Generation DBM
Early 1990s – First generation
Demineralized Bone Matrix (DBM)
formulations combined standard
processed particulate DBM with
an inert carrier for easy handling
and graft containment.
2nd Generation DBM + ABM
2002 – A patented process was developed
to transform particulate DBM into
a dispersed form of DBM. This patented
Accell Bone Matrix (ABM) is blended
with traditional particulate DBM and
an inert carrier to create our second
generation products.
3rd Generation Accell Evo3
2008 – With Accell Evo3, Integra optimized
the formulation of ABM, DBM, and RPM.
This third generation product includes three
times the amount of ABM as compared
to second generation products with
even better handling.
Superior Handling1
The optimized formulation of Accell Evo3 contains ABM and DBM combined with a unique poloxamer Reverse Phase Medium (RPM).
The result is a graft material with exceptional handling and containment characteristics.
The unique RPM carrier becomes more viscous
at body temperatures, while it is less viscous at
room temperature. Because of the RPM’s
unique thermoreversible property,
Accell Evo3 is:
•
•
•
•
Moldable at the time of application
Packable into virtually any size or shape defect
Mixable with other grafting materials
Irrigation-resistant
The optimized formulation of Accell Evo3 results
in a robust, moldable putty that does not stick to
surgical gloves.
The unique thermoreversible RPM carrier allows Accell Evo3 to resist
irrigation and graft migration.
Integra®
Accell Evo3® / Accell Evo3®c Accell Evo3®
Reference
Description
Size
02-5000-025
02-5000-050
02-5000-100 Putty (syringe)
Putty (syringe)
Putty (syringe) 2.5cc
5cc
10cc
Reference
Description
Size
02-6000-025
02-6000-050
02-6000-100 Putty (syringe)
Putty (syringe)
Putty (syringe) 2.5cc
5cc
10cc
Accell Evo3®c
References
1. Data on file.
2. Khaliq S, Lollis R, Bell D, Oliver R, Walsh WR, and Ingram R, Evaluation of a Next Generation DBM Putty in a Posterolateral Spinal Fusion Model, (2009) Integra LifeSciences Corporation.
3. Asdourian P, Case Presentation on the use of Coral® Spinal System in Lumbar Fusion, (2011) Integra LifeSciences Corporation.
4. Barry J, Case Presentation on Lumbar Spine Fusion using Integra’s 3rd Generation DBM Putty, (2012) Integra LifeSciences Corporation.
Indications for Use
Accell Evo3®
Accell Evo3 Demineralized Bone Matrix is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3 is indicated for use as a bone graft extender in the spine, extremities and pelvis. Accell Evo3 may also be used as a bone void filler in the posterolateral spine, extremities and pelvis. The voids or gaps may be surgically created defects or the
result of traumatic injury to the bone.
Acell Evo3®c
Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c 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 Evo3 and Evo3c are 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 packaging 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 Evo3 and Accell Evo3c have 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. When filling a closed defect, care must be taken while extruding Evo3 or Accell Evo3c from the syringe as possible pressurization of the device could result in fat embolization and/or embolization of the material into the blood stream. 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. If any dissatisfaction with the product performance or packaging occurs, notify Integra LifeSciences immediately and promptly return product and/or packaging. When introducing Accell Evo3 or Acell Evo3c, care must be taken 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.
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
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Accell Evo3, Accell Connexus, DynaGraft, Coral, 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. 0k 00002208