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Transcript of Sports Surgery Line - Bone regeneration eXperts -...
eXperts in bone regeneration
Osteotwin™
Sports Surgery Line
When Innovation Meets Performance
3
Burden of Proof
Mineral
BonePhase
Bioactivity
MB
CPmicroporositymacroporosity
calciumphosphate
biphasic
Sports Surgery Line
Our MBCP™ Technology
For more than 20 years, our philosophy has been to develop performing and safe solutions for regenerative
surgeries. Backed by this extended clinical background, we invite you to discover our innovative and unique
Sports Surgery Line. Join us into the new era, When Innovation Meets Performance.
More than 650 published studies, with 30 years of clinical experience
Biomatlante’s Bone Scaffolds have evolved to meet new biotechnological requirements stemming from tissue
engineering where surgeons need to combine scaffolds with biological fluids (bone marrow or mesenchymal stem
cells) or active agents.
Biomatlante leads the way in the development of synthetic bone scaffolds for use in numerous research programs
seeking to improve outcomes for particularly challenging patients.
The performance of MBCP™ is characterized by:
• Equivalent clinical outcome to autologous bone graft;• Fewer wound healing problems than autologous grafts;• Avoidance of donor site pain and infections;• No allergenic reactions1.
macroporosity
microporosity
100 µm2 µm
Level Title AuthorsStudy Type
Patients Number
Randomized & Controlled
1« Synthetic porous ceramic compared with autograft in scoliosis surgery. A prospective, randomized study of 341 patients. » (1998)
A. O. Ransford, T. Morley, M. A. Edgar, P. Webb, N. Pas-suti, D. Chopin, C. Morin, F. Michel, C. Garin, D. Pries.
Prospective 341
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Osteotwin™
Interference ScrewOsteotwin™ was designed to fulfill two core aims: provide appropriate mechanical properties necessary for ligament reconstruction whilst ensuring a regulated resorption and osteointegration to form architectural bone through hydrolysis.
Design
The thread is specific to each screw diameter so as to systematically provide the maximum amount of contact between implant and bone.
Specific design thread for optimal contact
Smooth thread to minimize damage on ligament
Graduated tapered design to optimize torque
Screw tip tailored to assist insertion into the bone tunnel
Auto stopper half head design
The conical tip is shorter
to increase threaded
screw contact
Length 20Lengths 25 & 30
Headless to maximize
the length of the screw
ACL Fixation System
Knee Cruciate Ligament Reconstruction Attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur
Specific screwdriver connection design to provide optimal distribution of forceThe mean failure torque for Osteotwin™ is 6 N.m, whereas other leading implants show a breakage rate of 5 and 5,3 N.m*.
Mineral
BonePhase
Bioactivity
MB
CPmicroporositymacroporosity
calciumphosphate
biphasic
5
Co
mp
osite S
crewPolylactic & Composite Screws
75% PLDLLA & 25% BCP: the ideal ratio between the necessary mechanical resistance for the indication and the faculty to generate bone growth.
KEY FEATURES KEY BENEFITS
Biocompatible No rejection
Bio absorbable Non obstructive, in event of revision
Metal-like mechanical properties Necessary for indication requirements
Polymer & Ceramic Bioactive3
pH Neutral No reported cases of inflammation or kysts (out of 30,000 cases)
Positive clinical response Architectural bone growth
MBCP™ Technology Greater corticalization*
Organic MatrixPolylactic Acid
Mineral ChargeBiphasic Calcium Phosphate
Polylactic ScrewPLDLLA Only
75%
PLD
LLA
MBCP™ Technology
PLDLLA
25% MBCP™ Technology
Composite ScrewOptimal BalanceOp
Promotes the scaffold effect for osteoconduc-tion and osteogenesis during the resorption of
the polymer by hydrolysis
For bioactive ionic exchange: TCP dissolution and bony crystal precipitation. Newly bioactive
interface with bone cells
Regeneration of architectural bone
Better balance between degradation and mechanical strength than PLGA or PLA
L-Lactide provides greater mechanical resistance
DL-Lactide is amorphous (the crystallinity has been removed) which increases the
resorption rate
100% PLDLLAMineral
BonePhase
Bioactivity
HA β-TCP
MB
CPmicroporositymacroporosity
calciumphosphate
biphasic
Po
lylacticS
crew
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Osteotwin™ ACL Fixation System
Affix Sheath
Affix Sheath is designed to increase soft tissue fixation in ACL reconstruction surgery. Using Affix Sheath guarantees superior fixation strength* and greater graft protection.
Tested in a porcine tibia with human hamsting tendon* All screws lengths: 25 mm
Osteotwin™ Affix Sheath is an innovative and unique Tibial Fixation Device.
Easy & Safe
Design
Rotational locking system during screw insertion
Guide wire friendly
125%
100%
150%
+24.45%+30.33%
8 mm 7-8 mm 9 mm 9-10 mm
Average Failure LoadsScrew vs. Screw + Sheath
Single Strand
125%
100%
150%
+24.45%
+54.87%
7 mm 7-8 mm 8 mm 7-8 mm
Average Failure LoadsScrew vs. Screw + Sheath
Double Strand
296 420 273 413326 400 500 651
125%
100%
150%
+24.45%+30.33%
8 mm 7-8 mm 9 mm 9-10 mm
Average Failure LoadsScrew vs. Screw + Sheath
Single Strand
125%
100%
150%
+24.45%
+54.87%
7 mm 7-8 mm 8 mm 7-8 mm
Average Failure LoadsScrew vs. Screw + Sheath
Double Strand
296 420 273 413326 400 500 651
Expandable
Self opening stabilization system
Interior threading can be used with both Polylactic and Composite screws
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Product References
Osteotwin™ ACL Fixation System
Class III Medical Device According to EU Directive EEC/93/42
Screws
Sheaths
7 mm 8 mm 9 mm 10 mm 11 mm 12 mm
20 mmComposite 11CPVI0720 11CPVI0820 11CPVI0920 -
Polylactic 13PVI0720 13PVI0820 13PVI0920 -
25 mmComposite 08CPVI0725 08CPVI0825 08CPVI0925 12CPVI1025
Polylactic 13PVI0725 13PVI0825 13PVI0925 13PVI1025
30 mmComposite 08CPVI0730 08CPVI0830 08CPVI0930 08CPVI1030
Polylactic 13PVI0730 13PVI0830 13PVI0930 13PVI1030
35 mm Composite 15CPVI1135* 15CPVI1235*
Length
Diameter
Reference
7 - 8 mm 14CPCH0725
9 - 10 mm 14CPCH0925
* Coming soon
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Osteotwin™ ACL Fixation System
Instrumentation
Modular Screw System
Osteotwin™ Kits
Sheath Instrumentation
Screw Modular System
Screw Classic System
Screw Dilator System
Osteotwin™ Intrumentation Kits have been developed with two main goals in mind: insure the quality of surgical procedures with dedicated high quality tools; and save you time during surgical procedures with color coding. These Instrumentation Kits are fully customizable.
Rachet Handle Screwdriver Shaft Starter Tap Shaft
14INPO001 14INTO001 14INTA001
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Classical Screw System
Dilator Screw System
Sheath Instrumentation
Dilator Sheath Inserter Sheath
Tunnel Dilator Screw
08INCO001
14INDI001
Starter Tap
11INTA001
14ININ001
Screwdriver
08INTO001
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Osteotwin™ High Tibial Osteotomy
MBCP™ Wedges
Made of MBCP™, the reference in osteoconductive bone graft substitute, they are a biphasic calcium phosphate made of 60% hydroxyapatite (HA) and 40% Beta-Tricalcium Phosphate (ß-TCP), allowing for simultaneous controlled adsorption and promotion of osteogenesis.
Biomatlante recommends these HTO plate specialists:
Controlled resorption, osteogenic and osteoconductive
Custom design — Standard design
20 years of proven efficacy
High Tibial Osteotomy MBCP™ Wedges are designed to precisely fit within the shape of the opened wedge correction.
While MBCP™ Wedges have a high compressive force of 10-12MPa, they are intended for use with rigid fixation systems.*
11
Osteotwin™ References & Bibliography
1. Daculsi, G., O. Laboux, et al. (2003). «Current state of the art of biphasic calcium phosphate bioceramics.» Journal of Materials Science: Materials in Medicine 14(3): 195-200.
2. Middleton, J. C. et al.; Biomaterials 21 (23), «Synthetic biodegradable polymers as orthopedic devices», 2000 2335-2346.
3. Suchenski, M., M. B. McCarthy, et al. (2010). «Material Properties and Composi-tion of Soft-Tissue Fixation.» The Journal of Arthroscopic and Related Surgery 26(6): 821-831.
4. Uzel, A. P., E. Seris, et al. (2013). «Preclinical and clinical cases of new absor-bable composite interference screws in osteoarticular surgery.» Key Enginee-ring Materials 529-530: 325-330.
5. Kaeding, C., J. Farr, et al. (2005). «A Prospective Randomized Comparison of Bioabsorbable and Titanium Anterior Cruciate Ligament Interference Screws.» The Journal of Arthroscopic and Related Surgery 21(2): 147-151.
6. Hunt, J. A. and J. T. Callaghan (2008). «Polymer-hydroxyapatite composite versus polymer interference screws in anterior cruciate ligament reconstruction in a large animal model.» Knee Surgery, Sports Traumatology, Arthroscopy 16(7): 655-660.
7. Weiler, A., H. J. Windhagen, et al. (1998). «Biodegradable interference screw fixation exhibits pull-out force and stiffness similar to titanium screws.» The American journal of sports medicine 26(1): 119-126.
8. Weiler, A., R. F. Hoffmann, et al. (1998). «Hamstring tendon fixation using inter-ference screws: a biomechanical study in calf tibial bone.» Arthroscopy: The Journal of Arthroscopic and Related Surgery 14(1): 29-37.
9. Black, J., (1988). «Does corrosion matter?» The Journal of Bone and Joint Surgery, 70-B(4): 517-520.
10. Bauer, J., Turgay, E., et al. (2010)., «Torsional stability of interference screws derived from bovine bone - a biomechanical study.» BMC Musculoskeletal Disorders 11: 82
11. Uzel, P. A., G. Daculsi, et al, «Utilisation des coins de MBCP™ en traumatologie lors des fractures enfoncement (tibia proximal et distal, calcanéum) : double intérêt de comblement et d’étayage», 13ème Congrès de l’AOLF (2012)
12. R. Schouten, G. Hooper, The use of Bone substitute (Triosite) wedges in Medial Opening wedge high tibial osteotomies, 33 Patient clinical study, Journal of Bone & Joint Surgery, British Volume (2009)
13. Rouvillain, J.L., Lavalle, F., Pascal-Mousselard, H., Catonne, Y., Daculsi, G., Clini-cal, radiological and histological evaluation of biphasic calcium phosphate bio-ceramic wedges filling medial high tibial valgisation osteotomies., Knee (2009)
14. Rouvillain, J. L., Pascal-Mousselard, H., Lavalle, F, Garron E., Catonné Y., Daculsi G., MBCP Wedges performance during open medial tibial osteotomy, European conference on biomaterials (2006)
15. Lavallé, F., H. Pascal-Mousselard, et al, Biphasic ceramic wedge and plate fixa-tion with locked adjustable screws for open wedge tibial osteotomy, Revue de chirurgie orthopédique (2004)
* Data on files, Biomatlante
1. A.O. Ransford et al., “Synthetic porous ceramic compared with autograft in sco-liosis surgery. A prospective, randomized study of 341 patients.” J Bone Joint Surg Br, 1998. 80(1): 13-8.
2. F. Gouin, J. Delecrin, N. Passuti, S. Touchais, P. Poirier, J. Bainvel “Biphasic macroporous calcium phosphate ceramic bone substitute for filling bone de-fects: A report of 23 cases.” Revue de Chirurgie Orthopedique: 81; 59–65 (1995).
3. G. Daculsi, P. Corlieu, M. D’Arc, M. Gersdorff “Macroporous biphasic calcium phosphate efficiency in mastoid cavity obliteration: experimental and clinical findings.” Annals of Otology, Rhinology & Laryngology: 101 (8); 669–674 (1992).
4. G. Daculsi, N. Passuti, S. Martin, C. Deudon, R. Legeros, S. Raher “Macroporous calcium phosphate ceramic for long bone surgery in humans and dogs. Clinical and histological study.” Journal of Biomedical Materials Research: 24; 379–396 (1990).
5. G. Daculsi, F. Jegoux, an P. Layrolle (2009). «The micro macroporous biphasic calcium phosphate concept for bone reconstruction and tissue engineering», Advanced Biomaterials: Fundamentals, Processing, and Application, B. Basu. et al., J. Wiley and sons Inc., pp 101-141
* Data on files, Biomatlante
• Read instructions for use for a complete list of warnings, precautions, possible adverse events and other important medical information.
• Not all products are registered or available in every country/region. Please check with Biomatlante representative for availability and further information.
Osteotwin™ & MBCP™ are trademarks of Biomatlante, SA.This document is not applicable for the US.
Notes
MBCP™ Technology
Osteotwin™
Backed by 20 years of experience in the development and manufacturing of synthetic bone substitutes, Biomatlante readily meets the challenge of constantly evolving its product line to meet today’s market demands for new, more effective, generations of biomaterials and smart scaffolds for tissue regeneration and minimally invasive surgical technologies.
Biomatlante
Commitment We are committed to our industry – we feel we have a bond with physicians and patients alike.
Our Values
Integrity We treat people fairly and expect the same in return.
Quality We are committed to providing products of the highest quality – We never compromise!
PassionWe love what we do. Innovative bone regeneration solutions are truly our passion.
BIOMATLANTE5 rue Édouard Belin
Z.A. Les Quatre Nations44360 Vigneux-de-Bretagne
France
+33 (0)2 28 02 00 [email protected]
www.biomatlante.com
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