Accell Evo3™
3rd Generation Demineralized Bone Matrix Putty
Because we are committed to limiting uncertainty,
we continuously develop new biologic technologies
to complete the Integra biologic product line.
Specifications
• Accell Bone Matrix X 3
• Superior Handling
• Custom Syringe
• Integra DBM
• Ready to use
• Safety Through E-Beam Sterilization
PRODUCTS FOR SALE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY
Accell EVO3™
3rd Generation Demineralized Bone Matrix Putty
Evolution of DBM to the Demineralized Bone Matrix putty Accell Evo3™
2nd Generation DBM + ABM
1st Generation DBM
DBM
DBM
DBM
ABM
Early 1990’s
First generation Demineralized Bone
Matrix (DBM) formulations combined
standard processed particulate DBM
with an inert carrier for easy handling
and graft containment.
ABM
ABM
3rd Generation Accell EVO3™
Demineralized Bone Matrix
DBM
DBM
2002
A process was developed to transform
particulate DBM into a dispersed form
of DBM. This Accell™ Bone Matrix (ABM)
is blended with traditional particulate
DBM and an inert carrier to create our
second generation products.
ABM
DBMABM
DBMABM
ABM
2008
With Accell Evo3™ Demineralized
Bone Matrix, Integra optimized the
formulation of ABM, DBM, and Reverse
Phase Medicum (RPM). This third
generation product includes three
times the amount of ABM as compared
to second generation products with
even better handling.
Superior Handling2
The optimized formulation of Accell EVO3™ Demineralized
Bone Matrix 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, the
demineralized bone matrix putty 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™
Demineralized Bone Matrix results in a robust, moldable
putty that does not stick to surgical gloves.
The unique thermoreversible RPM carrier allows Accell Evo3™
Demineralized Bone Matrix to resist irrigation and graft migration.
Accell EVO3™ ▪ Demineralized Bone Matrix Putty
PRODUCTS FOR SALE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY
Accell EVO3™
3rd Generation Demineralized Bone Matrix Putty
Has your DBM evolved?
Accell™ Bone Matrix X 3
The demineralized bone matrix putty Accell Evo3™ contains 3 times more Accell Bone Matrix (ABM)
than the previous generation of Accell DBM products.*
This dispersed form of DBM offers significantly increased surface area, which provides access to
natural bone proteins.
Superior Handling
Accell EVO3™ Demineralized Bone Matrix incorporates a poloxamer Reverse Phase Medium (RPM),
a highly biocompatible carrier.
This unique thermoreversible carrier allows Accell EVO3™ Demineralized Bone Matrix to meet the needs of
challenging surgical applications where robust handling is essential.
• At room temperature, Accell EVO3™ Demineralized Bone Matrix
is malleable and easily extruded from the syringe
• At body temperature, Accell EVO3™ Demineralized Bone Matrix is more
viscous, resists irrigation and minimizes graft migration
Custom Syringe
The new ergonomic syringe design facilitates easy handling and extrusion of the graft.
The large diameter extrusion is ideal for graft mixing and placement.
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 ensure osteoinductive potential.1
Ready to Use
Accell EVO3™ Demineralized Bone Matrix is ready for implantation directly from the syringe.
It does not require any cumbersome or time‑consuming preoperative preparation such as thawing or mixing.
Safety Through E-Beam Sterilization
Integra utilizes electron beam (e-beam) sterilization to ensure product sterility. This process has
been shown to preserve the osteoinductive potential of DBM.1 All products are e-beam sterilized as
the last step in manufacturing prior to being shipped.
*compared to Accell Connexus™ 1
Accell EVO3™ ▪ Demineralized Bone Matrix Putty
PRODUCTS FOR SALE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY
Accell EVO3™
3rd Generation Demineralized Bone Matrix Putty
Pre-Clinical Radiographic Evidence: Comparison of 1st, 2nd, and 3rd Generation DBM Putties on New Bone Formation.3
1st Generation: DynaGraft® II
12 weeks
New bone has formed on both sides.
Fusion between the transverse
processes on the left is complete,
but is not continuous on the right.
3rd Generation: Accell EVO3™
Demineralized Bone Matrix
2nd Generation: Accell Connexus®
12 weeks
12 weeks
2nd Generation DBM resulted in
more new bone formation than 1st
Generation DBM. Both sides have
fused in a continuous manner.
3rd Generation DBM resulted in abundant
new bone formation on both sides,
creating a dense continuous fusion
mass between transverse processes
with new cortical periphery.
The Accell™ Advantage ▪ What’s the Difference?
Accell EVO3™ Demineralized Bone Matrix combines ABM and particulate DBM.
ABM1
Particulate DBM1
Standard Process
Accell Process
Ground Cortical Bone
30x
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 EVO3™
Demineralized Bone Matrix1
30x
Accell™ Bone Matrix (ABM)
is an open-structured,
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.4
Accell EVO3™ ▪ Demineralized Bone Matrix Putty
PRODUCTS FOR SALE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY
Accell EVO3™
3rd Generation Demineralized Bone Matrix Putty
What is Our Accell™ Bone Matrix?
Particulate DBM
ABM
Particulate DBM is formed by
removing the mineral component
of ground cortical bone.
Accell™ Bone Matrix is
transformed from particulate
DBM using the 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 growth factors,
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 growth factors in bone.
Accell™ Bone Matrix’s increased surface area
provides access to natural bone proteins.
Osteoinductive Potential ▪ In Vitro Measurement5
Accell™ Bone Matrix (ABM) vs. Demineralized Bone Matrix (DBM)
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.
The higher surface area and more open pore structure of ABM
provides accessibility to the bone protein, without the need to
be broken down.
This analysis shows that while ABM provided early accessibility
of natural bone protein, particulate DBM provides for
accessibility of natural bone protein at later time points.
Accell EVO3™ ▪ Demineralized Bone Matrix Putty
PRODUCTS FOR SALE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY
Accell EVO3™
3rd Generation Demineralized Bone Matrix Putty
Find out how you can Accell™
Contact Integra™ Customer Service
+1 (949) 595-8710 ▪ www.IntegraOrthoBiologics.com
Description
Catalog Number
2.5 cc syringe
02-5000-025
5 cc syringe
02-5000-050
10 cc syringe
02-5000-100
Indications for use
References
1. Data on file.
2. Compared to previous generations of Integra DBM products.
3. Preclinical data from rabbit spine fusion model on file.
4. Lian J and Stein G,
The Cells of Bone, (1999) Dynamics of Bone and
Cartilage Metabolism (Ed Seibel J).
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™ Demineralized Bone Matrix 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™ Demineralized Bone Matrix has been sterilised and keeps its properties during the stated
shelf life in an unopened and undamaged package. The product must be used prior to the expiration date.
5. R&D Systems, Inc.: Quantikine® - BMP‑2 Immunoassay,
For the quantitative determination of bone morphogenetic protein 2
(BMP‑2) concentrations in bone tissue extracts and cell culture supernates.
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
OrthoBiologics. 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™ Demineralized Bone Matrix 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. When filling a closed defect, care must be taken
while extruding Accell EVO3™ Demineralized Bone Matrix 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
OrthoBiologics immediately and promptly return product and/or packaging. When introducing Accell
EVO3™ Demineralized Bone Matrix, 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 the product insert.
Integra LifeSciences Services (France) SAS
Sales & Marketing EMEA
Immeuble Séquoia 2 ▪ 97 allée Alexandre Borodine
Parc technologique de la Porte des Alpes
69800 Saint Priest ▪ FRANCE
 +33 (0)4 37 47 59 00 ▪ fax +33 (0)4 37 47 59 99
emea.info@integralife.com ▪ integralife.com
Distributed by
Customer Service
International: +1 (949) 595 8710 • Fax: +1 (949) 595 8717 • irvine.cs@Integra-LS.com
IsoTis Orthobiologics
2 Good Year Suite A ▪ Irvine, CA 92618 ▪ United States of America
 +1 (949) 595 8710 ▪ fax: +1 949 595 8711 97
©2010 Integra LifeSciences Corporation. All rights reserved. ILS 09-01-014-01-10
PRODUCTS FOR SALE IN EUROPE, MIDDLE-EAST and AFRICA ONLY
Availability of these products might vary from a given country or region to another, as a result of specific local regulatory
approval or clearance requirements for sale in such country or region. ▪ Always refer to the appropriate instructions for use
for complete clinical instructions. ▪ Non contractual document. The manufacturer reserves the right, without prior notice,
to modify the products in order to improve their quality. ▪ WARNING: Applicable laws restrict these products to sale by or
on the order of a physician. ▪ Accell Evo3 Demineralized Bone Matrix, the running man logo, Integra and the Integra logo are
trademarks of Integra LifeSciences Corporation or its subsidiaries.