Accell Evo3™
Has your DBM
evolved?
DBM
ABM
RPM
Accell Bone Matrix X 3!
Accell Evo3™ contains 3 times more Accell Bone Matrix (ABM) than the previous generation
of Accell DBM products.*
This patented, dispersed form of DBM offers significantly increased surface area, which provides access to natural bone proteins.
DBM
ABM
RPM
Superior Handling
Accell Evo3 incorporates a poloxamer Reverse Phase Medium (RPM), a highly 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.
DBM
ABM
RPM
DBM
ABM
RPM
DBM
ABM
RPM
DBM
ABM
RPM
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 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
Find out how you can Accell
Contact Integra Customer Service
(800) 550-7155
www. IntegraOrthoBiologics .com
Reflex Blue
Accell Evo3
™
Description
5 cc syringe
10 cc syringe
2728
Catalog Number
02-5000-050
02-5000-100
Demineralized Bone Matrix Putty
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)
5. R&D Systems, Inc.: Quantikine(R) - BMP-2 Immunoassay, For the quantitative determination of bone morphogenetic protein 2 (BMP-2) concentrations in bone tissue extracts and cell culture supernates.
INDICATIONS FOR USE
Accell Evo3™ 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, 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 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 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 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 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, 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.
The Integra wave logo, Integra OrthoBiologics, Accell Evo3 and Bone Grafting, Naturally are trademarks of Integra LifeSciences Corporation or its subsidiaries. Accell, Accell Connexus and DynaGraft are registered
trademarks of Integra LifeSciences Corporation or its subsidiaries.
© Copyright 2008 Integra OrthoBiologics – 2 Goodyear, Irvine, CA 92618
NS2063-10/08