Frequently asked questions...
WHERE AND HOW ARE THESE PRODUCTS PRODUCED?
Integra is a registered tissue bank in the USA, and acquires the raw material from the AATB’s; Association of American Tissue Banks.
These are the most highly regulated in the world. Unlike other Companies Integra takes the bone and breaks it down in house, very
carefully, which is what allows us to produce a consistent product which retains the DBM and Growth Factors in large quantities.
At this point we test for osteoinductivity, and if the levels are not high enough to reach our standards, the batch is destroyed.
As you can imagine, donors come in all types, and just as in the living, the levels of osteoinductivity vary dramatically depending
upon age, health etc.
In production the DBM powder is split into two “piles”, then one lot is whisked in a way not dissimilar to producing candy floss, and that becomes our carrier, which is mixed back in with the raw DBM material. The whole is then mixed with a
little sterile saline to give the fluidity of the final product. In the case of
ACCELL DBM100, that is the final product, shelf life is
6 months, and it is putty. CONNEXUS has 70% DBM with 30% (Reverse Phase Medium) RPM, which gives the product improved handling
qualities and a two year shelf life, then ORTHOBLAST which is about 40% DBM derived including bone chips from the same donor, and 60%
RPM; You can choose, based on the health and condition of your patient, what level of Bone “Boost” you may require. The RPM is an added
constituent which gives our products much better handling qualities, a two year shelf life and also enables it to go harder when
placed in situ in the patient at body temperature, helping to make it resistant to both drain and sucker. That is harder,
NOT load bearing. This constituent is regularly found in cough mixtures, which gives them their “clinging” effect, and is
perfectly safe to use in all patients.
We have, without any doubt, the best available Orthobiologics range available in the world today.
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