Innovative Processing Method for Innovative Products
The bone tissue is procured, tested and processed according to the EU Directives and Austrian Tissue Law Österreichisches Gewebesicherheitsgesetz.
The essential characteristic of processing is that supercritical CO2 technology is used, currently the most gentle and effective technology of cleaning bone allografts.
Supercritical CO2 has the ability of high penetration throughout the whole bone matrix
combined with high potential to solve lipids and cellular components associated with lipids.(4)
Using this technology lipids and bone marrow are removed, while the collagen matrix consisting of collagen and minerals is mainly maintained. Osteoinductive proteins are treated with care. The native composition of the matrix promotes osteocunduction (6).
The virus-inactivating effect of the process has been validated several times (5). By removing fat and cellular components antigens are removed (7) and immunological reactions are avoided.
Because of the unique properties of supercritical CO2 this innovative processing technology enables efficient and gentle cleaning of human bone allografts – also for cortical and massive allografts – and guarantees ultimate biological safety and quality of the products.
Application and Bone Graft Impacting
Using mild to moderate impaction forces, depending on the required effect. Mild impaction will result in accelerated incorporation, moderate forces increase primary stability. Insertion of osteosynthetic material or endoprostheses may precede or follow the grafting procedure, according to local circumstances.
Safe, Clean and Efficient!
· The validated virus-inactivation grants ultimate safety. (5)
· Extraction of lipids and cellular components takes place deep into the bone matrix.
· The collagen matrix consisting of collagen and minerals is mainly maintained and
osteoinductive proteins are treated with care.
· The native composition of the matrix promotes osteocunduction. (6)
· The mechanical and structural qualities are mainly equal to those of unprocessed bone
· Using impaction grafting the primary stability of purified allografts is favourable compared
to not purified, fatty transplants. (2, 3)
· The cleaning process uses only non-toxic solvents.
· Processed chips, femoral heads and blocks have no immune response of the recipient.
· Incorporation at the recipient therefore takes place faster and more complete. (1, 6, 9)
· The allografts are double packaged in blisters or glass vials and sterilized.
· Storage takes place under room temperature conditions for up to 5 years.
· The products are easy to handle and user-friendly shaping saves time in the OR.
1. Aspenberg P, Thoren K. Lipid extraction enhances bank bone incorporation. An experiment in rabbits. Acta Orthop Scand 1990; 61-6:546-8.
2. Cornu O, Bavadekar A, Godts B, Van Tomme J, Delloye C, Banse X. Impaction bone grafting with freeze-dried irradiated bone. Part I. Femoral implant stability: cadaver experiments in a hip simulator. Acta Orthop Scand 2003; 74-5:547-52.
3. Cornu O, Bavadekar A, Godts B, Van Tomme J, Delloye C, Banse X. Impaction bone grafting with freeze-dried irradiated bone. Part II. Changes in stiffness and compactness of morselized grafts: experiments in cadavers. Acta Orthop Scand 2003; 74-5:553-8.
4. Fages J, Marty A, Delga C, Condoret JS, Combes D, Frayssinet P. Use of supercritical CO2 for bone delipidation. Biomaterials 1994; 15-9:650-6.
5. Fages J, Poirier B, Barbier Y, Frayssinet P, Joffret ML, Majewski W, Bonel G, Larzul D. Viral inactivation of human bone tissue using supercritical fluid extraction. Asaio J 1998; 44-4:289-93.
6. Frayssinet P, Rouquet N, Mathon D, Autefage A, Fages J. Histological integration of allogeneic cancellous bone tissue treated by supercritical CO2 implanted in sheep bones. Biomaterials 1998; 19-24:2247-53.
7. Thoren K, Aspenberg P, Thorngren KG. Lipid extraction decreases the specific immunologic response to bone allografts in rabbits. Acta Orthop Scand 1993; 64-1:44-6.
8. Thoren K, Aspenberg P, Thorngren KG. Lipid extracted bank bone. Bone conductive and mechanical properties. Clin Orthop Relat Res 1995-311:232-46.
9. Thoren K, Aspenberg P. Increased bone ingrowth distance into lipid-extracted bank bone at 6 weeks. A titanium chamber study in allogeneic and syngeneic rats. Arch Orthop Trauma Surg 1995; 114-3:167-71.