GRAFTYS® BCP is a safe and effective synthetic biomaterial. It is a bi-phasic phosphocalcic micro/macro porous ceramic where chemical composition has been balanced to provide a physiologic resorption/substitution process. The porosity structure has been fine-tuned by using a proprietary transitional porogenic process which improves interconnectivity and optimizes fluid percolation and cell invasion. GRAFTYS® BCP is available in a wide variety of shapes to address many clinical requirements.
Composition
GRAFTYS® BCP is composed of a 60%/40% mix of:
• HA : Hydroxyapatite, Ca10 (PO4)6 (OH)2, Bone-bonding material, low dissolution rate
• β-TCP: Beta Tricalcium Phosphate, Ca3 (PO4)2, high dissolution rate
Physicochemical properties
Available Initial Porosity
Global Porosity: 70% distributed as below:
• Micro porosity (<10 µm): 45%;
• Meso porosity ([10 - 100 µm]): 20%;
• Macro porosity (>100 µm): 35%
Mechanical compressive strength: >10 MPa. This product has to be used in an intrinsic stable site or in association with material which will stabilize the surgical site. Preparation GRAFTYS® BCP can be used either alone (moistening by sterile saline solution or water being better to avoid cells mortality by drying out) or with patient blood or bone marrow or as graft extender (eg. autologous grafting). Mechanism of action GRAFTYS® BCP is a macroporous biomaterial with a composition similar to the crystalline phase of the bone. The porosity structure of GRAFTYS® BCP can be fully penetrated by biological fluids and cells. β-TCP is partially dissolved before precipitating as apatite crystals on the HA structure. These apatite crystals, similar to native bone crystals, promote cellular adhesion to start the natural resorption cycle. The low dissolution rate of HA offers a stable scaffold needed for cells to form bone (rapid dissolution can lead to fibrosis and seroma). Bone formation occurs throughout the material and occurs simultaneously with resorption of the implant.
| Advantages | Benefits | |
|---|---|---|
| Biphasic 60% HA 40% Beta-TCP | 2 kinetics of resorption, material resorbs at similar speed that the new bone growths |
Avoid gap formation and fibrosis development instead of healthy mineralized bone |
| Porosity | Biological fluids and cells colonization throughout the implant |
Fluids and cells are able to penetrate into the core of the material for a full remodeling of the implant |
| Macro porosity | 35% of pores >100µm |
Resorption can be achieved from the core of the structure |
| Mechanical strength | >10 MPa |
Easy to manipulate intraoperatively |
| Numerous generic and anatomical Shapes and volumes | Large coverage of applications |
Avoid losing time to adapt grafting material to each application. Can be used as graft extender. |
| Radio opacity | Visible on X-Rays and Scans |
Easy to follow post-op remodeling |
GRAFTYS® BCP is intended for use as a bone voi d filler for voids or gaps of the skeletal system caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. GRAFTYS® BCP can be used with autograft as a bone graft extender.
Contact international
Eiffel Park - Bâtiment D
415, rue Claude Nicolas Ledoux
Pôle d'Activités d'Aix en Provence
13 854 AIX EN PROVENCE Cedex 3
Office : +33(4) 42 60 30 00
Fax : +33(4) 42 60 30 11
France
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Contact USA
NaviMed International LLC
US representation for Graftys SA
office: 847-573-1028
fax: 847-557-9089
Chicago, IL, USA
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