ACCELL™
ACCELL™
A Technological Leap. A New Standard.
A Technological Leap. A New Standard.
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Bone Healing Process
Bone contains natural BMPs and growth factors which have been
shown to be a critical component in bone formation and healing.
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5, 14, 16, 17
The body’s natural response to traumatic injury is to initiate
healing through a complex and highly regulated series of events:
Accell 100™
Reference
Description
02-1000-010
1 cc syringe
02-1000-050
5 cc syringe
02-1000-100
10 cc syringe
ACCELL™ • ENGLISH
/STEOINDUCTIVE
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The Critical Role of BMPs and Growth Factors in Bone Formation and Healing
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• Stem cell and osteoblast recruitment
(chemotaxis)
Accell Connexus™
• Blood vessel establishment (angiogenesis)
Reference
Description
02-3000-005
0,5 cc syringe
02-3000-010
1 cc syringe
02-3000-025
2,5 cc syringe
02-3000-050
5 cc syringe
02-3000-100
10 cc syringe
• Cell replication (mitogenesis)
• Stem cell differentiation into osteoblasts
(osteoinduction)
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The Accell™ Advantage
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Accell TBM®
Reference
Description
• Skeletally mature sheep model
02-4000-220
2 x 2 x 0.5 cm square
• Cylindrical 5mm metatarsal defect created in tibial diaphysis
02-4000-520
5 x 2 x 0.5 cm strip
02-4000-550
5 x 5 x 0.5 cm square
02-4000-760
7 x 0.6 cm round
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• Results after 4 weeks
BONE GRAFTING, NATURALLY™
Accell 100™
Control - Empty
1st Generation DBM
Accell™
Accell Connexus™
Minimal bone regeneration
observed at 4 weeks. Healing
limited to area adjacent to host
bone.
Bone regeneration occurs
throughout the defect,
caused by the presence of
osteoinductive DBM particles.
The inert carrier has been
metabolized. (DynaGraft II®)
Significantly more bone
formation is evident
immediately adjacent to the
bone repair surfaces and within
the interior of the defect.
Accell TBM®
Distributed by
• These products may or may not be available in any particular country or region of the world as they
may or may not be approved or cleared by a government regulatory body for sale in different countries.
Integra LifeSciences Services (France) (Sales and Marketing)
66, quai Charles de Gaulle • 69463 Lyon Cedex 06 • FRANCE
&+33 (0)4 37 47 59 00 • fax +33 (0)4 37 47 59 99
emea.info@Integra-LS.com • www.Integra-LS.com
www.integraorthobiologics.com
Note: Sections stained for quantitative assessment of bone healing.
• ACCELL, TBM, Connexus, DynaGraft II, Accelerating Innovation in Orthobiologics and the Integra wave
logo are registered trademarks or trademarks of Integra LifeSciences Corporation or its subsidiaries.
International Customer Service
& +1 (949) 595-8710 • Fax: +1 (949) 595-8711
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• 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.
irvine.cs@Integra-LS.com
©2008 Integra LifeSciences Corporation. All rights reserved. ILS 09-01-001-01-08
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ISOTIS Orthobiologics
2 Good Year • Irvine, CA 92618 • United States of America
& +1 800 550 7155 • fax: +1 949 595 8711
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ORTHOBIOLOGICS
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ACCELL™
A Technological Leap. A New Standard.
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The Accell™ Process*
Accell 100™
Accell TBM®
Incorporates
• Accell™ Technology
DBM
Lot Division
Each donor lot of DBM is divided in two.
Half is reserved for the final formulation.
Solubilization
The remaining half undergoes the
Accell™ process which results in flowable
carrier with osteoinductive potential.
B
Lot Division
Solubilization
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• IsoTis® Processed DBM
• 0% Inert Carrier
• Matrix formulation through lyophilization
Benefits
Benefits
• Validated Osteoinductive Potential
• Validated Osteoinductive Potential
• Moldable and easy to pack into defects
• Available in different sizes
• Ready to use
• Easily cut to fit any size or shape of the defect
• Osteoconductive framework
Case Studies
• Ready to use
• Spine: Intertransverse process fusion 1
Soluble DBM
• Accell™ Technology
• IsoTis Processed DBM
®
A
Incorporates
• Hand: Cystic scaphoid nonunion 2
Case Studies
• Foot & Ankle:
- Tibial osteotomy 3
- Hindfoot and ankle nonunions 4
• Spine: Laminectomy and spinal fusion 10
• Spine: Posterolateral Spinal Fusion 18
Ready to use
• Trauma: Humeral nonunion 11
• Hip: Total hip revision 12
Final Formulation
The flowable carrier is then combined
with the DBM particles consisting of
two components with osteoinductive
potential.
Final Formulation
Accell
DBM
• Knee: Total knee revision 13
• Foot & Ankle: Tibial osteotomy 3
Accell Connexus™
• Foot & Ankle:
- Tibial osteotomy 3
- Hindfoot and ankle nonunions 4
Incorporates
• Accell™ Technology
• IsoTis® Processed DBM
Final Product Configuration
• 30% Poloxamer Reverse Phase Medium Carrier (RPM)
Benefits
E-Beam Sterilization
IsoTis® terminally sterilizes every lot
of Accell™ product with a low-dose
electron beam, a process that has
been demonstrated to preserve the
osteoinductive potential of bone growth
factors.
References
• Validated Osteoinductive Potential
Sterilization
• Poloxamer Reverse Phase Medium
- Thickens at body temperature
- Resists irrigation allowing for better graft containment
- Is inert, biocompatible and safe6
• Moldable and easy to pack into
virtually any size or shape defect
• Ready to use
Case Studies
• Knee: Total knee replacement 7
• Foot & Ankle:
- Subtalar arthrodesis 8
- Hindfoot and ankle nonunions 4
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“Accell Total Bone Matrix showed
both radiographical and histological
equivalence to autograft, the established
gold standard, at six weeks.” 15
- Thickens at body temperature
- Resists irrigation allowing for better graft
containment
- Is inert, biocompatible and safe6
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1 Blumberg KD: The use of a novel DBM putty in a lumbar laminectomy and intertransverse process fusion. Case Study, 2004.
2 Geissler WB: Bone graft substitutes in the upper extremity. Hand Clinics 2006; 22(3): 329-339.
3 Keppler L: The use of Accell DBM 100™ and Accell TBM® in a proximal tibial osteotomy for left medial joint osteoarthritis. Case Study, 2006.
4 Rodriguez ER, et al: Use of high concentrate demineralized bone matrix in ankle and hindfoot orthopedic procedures. The Podiatry Institute Update 2005, Chapter 45, pages 234-237.
5 Wozney J.: Overview of bone morphogenetic proteins. Spine 27(16S), 2002
6 Li C, et al: Disposition of poloxamer 407 in rats following a single intraperitoneal injection assessed using a simplified calorimetric assay. J Pharm Biomed Anal 1996;14:659-665.
7 Keppler L: The use of Accell Connexus™ in a right total knee replacement with allograft reconstruction of extensor mechanism. Case Study, 2006.
8 Keppler L: The use of Accell Connexus™ in a subtalar arthrodesis of the left foot. Case Study, 2006.
9 Clokie ML, Urist MR: Bone morphogenetic protein excipients: Comparative observations on poloxamer. Plastic & Reconstructive Surgery 2000; 105(2): 628-637.
10 Keppler L: The use of Accell TBM® in a decompressive laminectomy at L4 and L4-L5 with spinal fusion at L4-L5 to treat hemangioma with an L4 fracture. Case Study, 2006.
11 Tom JA, et al: Humeral non-unions treated successfully with internal fixation and demineralized bone matrix. Case Study, 2006.
12 Johanson NA, Cerynik DL: Filling acetabular defects with preformed demineralized bone matrix in revision total hip arthroplasty. Case Study, 2006.
13 Bezwada HP, et al: Distal femoral allograft reconstruction for massive osteolytic bone loss in revision total knee arthroplasty. Case Study, 2006.
14 Cheng H, et al: Osteogenic activity of the fourteen types of human bone morphogenetic protiens (BMPs). J Bone and Joint Surgery 2003; 85-A(8): 1544-1552
15 Kay JF: Accell TBM® versus autograft in a critical size defect study. IsoTis White Paper, 2004.
16 Urist ML: Bone: Formation by autoinduction. Science 1965;150:893-899.
17 Blum B, et al: Measurement of bone morphogenetic proteins and other growth factors in demineralized bone matrix. Orthopedics, January 2004 (Supplement): 161-165.
18 Isaza J, et al: Fusion success with Accell Total Bone Matrix and autograft: 1 year post-surgical fusion rates in posterolateral spinal fusion. Retrospective study, 2007
* The Accell products are protected by one or more of the following U.S. Patent Nos 7,241,813, 7,205,337, 7,132,110, 6,309,659, 6,623,748 and other patents
pending in the U.S. and other countries.
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