In`Oss - Biomatlante

Transcription

In`Oss - Biomatlante
™
In’Oss
MBCP™ Technology
Moldable Synthetic Bone Graft
Microporous Resorbable
Biphasic Calcium Phosphate
In’Oss™
Moldable Synthetic Bone Graft
Microporous Resorbable Biphasic Calcium Phosphate
In’Oss™ is an innovative and moldable bone graft,
developing on MBCP™ Technology. It is composed
of Hydroxyapatite (HA), Beta tricalcium phosphate
(ß-TCP) and a hydrogel.
Developped to improve clinician handling during bone
grafting procedures, In’Oss™ can fit into different
grafting sites.
for rapid vascularization and mineralization.
In’Oss™ keeps the original graft
shape and bone volume. It
gradually absorbs over a
few months and is
replaced by vital
architectured bone.
In’Oss™, is the optimal balance between MBCP™ micro
granules and an absorbable hydrogel, acting as a carrier
Unique Concept for Bone Augmentation
In’Oss™ has an interconnected microporous structure.
The Hydrogel creates extra spaces for cell spreading and fluid diffusion
between MBCP™ microporous particles.
In’Oss™ chemistry encourages the rapid formation of natural bone and the
growth of capillary blood vessels throughout the matrix.
These materials have been shown to be perfectly biocompatible and
absorbable.
Resorbable / No wash-out /
Maintain volume stability / Superior handling characteristics
4 months bone remodelling with haversian
system - Goat model
Ready to use
In’Oss™ is supplied in a sterile syringe. In’Oss™ plasticity molds into the graft
site.
Safe
Interconnected structure between the
microporous granules and hydrogel
In’Oss™ is a safe, completely synthetic product with excellent proven
biocompatibility. In’Oss™ uses the core MBCP™ Technology to promote and
regenerate high quality bone. This technology has been at the center of
extensive clinical studies over the last 30 years (more than 600 publications)
with results comparable to autologous bone.
Easy & Fast
In’Oss™ placement
Bony crystals precipitation
Cells spreading
Architectured bone growth at the
expense of the bone graft
Concept
MBCP™ microporous granules
Hydrogel
In’Oss™ - Microporous Interconnected
particules
Complete and progressive vital bone regeneration
Clinical results for bone cyst
Dr Vogt F. , Cannes, France
Pre-op
Post-op
Vertebral body reconstruction
6 months
PEEK cage filling
PEEK Cages
MBCP™ granules
Vertebral body filling with In’OssTM, goat 6 months.
The trabeculae bone’s mimics grew inside at the expense of the
putty. The bone trabeculae integrate the not yet absorbed MBCPTM
granules of In’OssTM. The bone trabeculae are interconnected and
mimicking the spongious bone.
PEEK cage filled with In’OssTM, goat model 6 months.
Bone regeneration appeared from the two vertebral plates,
at the expense of the In’OssTM. Only a few residual MBCPTM
granules remain, included in the bone trabeculae (white
spot). They will be progressively absorbed during bone
remodelling
Photos: courtesy of Prof. Daculsi
Minimal invasive surgery in spine, new development of injectable ceramic MBCP
for vertebral body bone filling: in vivo experiment, G. Daculsi, H. Mousselard, E.
Goyenvalle, P. Pilet, S. Delplace, E. Aguado, Key Engineering Materials Vols. 284286 (2005), pp.803-806
Photos: courtesy of Prof. Daculsi
Les cages intervertébrales cervicales, analyse critique de la littérature,
H. Pascal-Mousselard, G. Daculsi, JY Lazennec, Y. Catonné, G. Saillant,
Maîtrise Orthopédique 2005, 147 : 8-17Vols. 361-363 (2008) pp. 12951298
* PEEK cage
Femoral head osteonecrosis
Defect filled with
the material
Post-op filling area
12 months - Bone regeneration is observed at
the expense of the In’OssTM putty bone graft
Photos: courtesy of Prof. Daculsi
Pilot Study of Safety and Performance of a Mixture of Calcium Phosphate Granules Combined with Cellulosic-derived Gel after Tunnel Filling Created during Surgical Treatment of
Femoral Head Aseptic Osteonecrosis, T. Fabre, D. Chauveaux, M. Moinard, C. Mais, M. Durand, C. Pollart and G. Daculsi, Key Engineering Materials Vols. 361-363 (2008) pp. 1295-1298
References
References
1ml
1 syringe
1003PU010R
2,5ml
1 syringe
1105PU025OR
5ml
1 syringe
1106PU05OR
10ml
1 syringe
1107PU010OR
ISO 13485
Read the instructions for use
Medical Device: Class III
Biomatlante Therapeutical Solutions
Ortho
Tumors, Cysts, Geode, Chondoma
Osteotomy
Pseudarthrosis
RECONSTRUCTION
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Cotyle Revision
Femur revision
Total knee revision
Total hip revision
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TRAUMA
Tibial plateau fracture
Calcaneum fracture
Tibial and Femoral fracture
Distal radius fracture
Association with osteosynthesis
Traumatology humerus
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SPINE
Cervical Spine cage insert
Lumbar Spine cage inserts
Posterior lateral graft
Cystique resection
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References
1.
2.
3.
4.
(2005) A New Injectable Bone Substitute Concept (MBCP Gel ™): First Clinical
Results in Human Maxillo-Facial Surgery, Key Engineering Materials Vols. 284-286
pp. 1053-1056
Fabre, T., Chauveaux, D., Moinard, M., Mais, C., Durand, M., Pollart, C.,Daculsi, G.
(2008) Pilot Study of Safety and Performance of a Mixture of Calcium Phosphate
Granules Combined with Cellulosic-derived Gel after Tunnel Filling Created during
Surgical Treatment of Femoral Head Aseptic Osteonecrosis, Key Engineering
Materials Vols. 361-363 pp. 1295-1298
5.
Pascal-Moussellard, H., Aguado, E., Catonné, Y., Rouvillain, J.L., Daculsi, G. (2003)
Evaluation of an intervertebral cervical cage filled with injectable bone substitute,
Cervical Spine Research Society (poster)
Daculsi, G., LeGeros, R., T. Kokubo (2008) Tricalcium phosphate/hydroxyapatite
biphasic calcium phosphate (BCP) bioceramics , in Bioceramics and theirs clinical
applications, editor, Woodhead publishing, pp 395-4242
6.
Davy, A., Gauthier, O., and al. (2004) Assessment of Cancellous Bone Architecture
after Implantation of an Injectable Bone Substitute, Catherine., Key Engineering
Materials Vols. 254-256 pp. 55-5842
7.
Daculsi, G., Lazennec, J.Y., Catonné, Y., Saillant, G., Pascal-Mousselard, H. (2008)
Les cages intervertébrales cervicales, analyse critique de la littérature, Maîtrise
Orthopédique 2005, 147 : 8-17Vols. 361-363 pp. 1295-1298
Daculsi, G., Mousselard, H., Goyenvalle, E., Pilet, P., Delplace, S., Aguado, E. (2005)
Minimal invasive surgery in spine, new development of injectable ceramic MBCP
for vertebral body bone filling: in vivo experiment, Key Engineering Materials Vols.
284-286, pp.803-806
Weiss, P., Clergeau, L.P., Enckel, B., Amouriq, Y., Giumelli, B., Jean, A., Daculsi, G.,
* Data on files, Biomatlante
Manufacturer :
Biomatlante
ZA Les Quatre Nations
5 Rue Edouard Belin
44360 Vigneux de Bretagne - France
Distributed by:
www.biomatlante.com
MBCP™ and In’Oss™ are trademarks of Biomatlante
Copyright @ Biomatlante - FT2013009MOS2 - Mise à jour : 06/2013
Bone filler