News
Kuraray Co., Ltd. (Headquarters: Chiyoda-ku, Tokyo; President: Masaaki Ito) hereby announces that AFFINOS, a bioresorbable bone-graft substitute that the Company has created using Beta-tricalcium phosphate (β-TCP), will be on the market from November 2, 2015.
1.Background of Development
In Japan, autologous bone-graft has been the predominant method used to treat bone defects and other conditions requiring bone grafting. However, in the interest of reducing the pain on patients while enhancing quality of life, development efforts have focused on creating artificial bone-graft materials capable of substituting for autologous bone-graft.
In 2009, Kuraray released REGENOS, a bone-graft substitute medical device made of hydroxyapatite. Building on this achievement, Kuraray has been developing AFFINOS to accommodate growing demand associated with bone regenerative medicine for bioresorbable implant materials that can be replaced by living bone. AFFINOS helps round out the Kuraray’s product lineup, and its introduction will boost Kuraray’s operations in the bone-graft substitutes market.
2.Features of AFFINOS
- Incorporatingβ-TCP as its ingredient, AFFINOS boasts superior biocompatibility and is resorbed and replaced by living bone after implantation.
- AFFINOS’s unique structure of numerous interconnected pores aligned in the one direction, allows blood and cells from surrounding tissue to smoothly penetrate its interior spaces, facilitating the ingrowth of blood vessels and bone tissue.
- AFFINOS has an anisotropic structure akin to that of living bone.
- The rates of new bone formation and that of material resorption are optimally balanced.
- The lineup includes granules, cubes, cuboids and cylinders.
Specifications
| Porosity | 57±5% |
|---|---|
| Compressive Strength | more than 8 MPa (in the direction of unidirectional pores); more than 1.5 MPa (in the direction perpendicular to unidirectional pores) |
3.Product Overview
| Classification | Specially controlled medical device (Class IV) |
|---|---|
| General name | Bioresorbable bone-graft substitute |
| Product name | AFFINOS |
| Marketing approval number | 22600BZX00536000 |
| Marketing approval holder | Kuraray Co., Ltd. |
| Type | Granular, cube, cuboid and cylinder |
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