Augment™ Injectable
In many foot and ankle fusion surgeries, bone has
to be harvested from another area of your body (such as the hip,
knee, shin or heel) to enhance bony healing at the primary fusion
site.Harvested bone,
known as autograft, has been successfully used in orthopedic surgery
for decades.In spite of
this, the use of autograft has some significant drawbacks, including
the potential for increased operative time and the potential for
post-operative pain at the harvest site.
The investigational device, Augment™ Injectable,
has been designed as a replacement for autograft and the need for a
second surgical procedure.
Augment™ Injectable is a bone substitute that is made up of two
components. One is a
synthetic bone-like material called beta-tricalcium phosphate
(β-TCP) combined with collagen (a substance similar to gelatin) and
a synthetic protein called recombinant human platelet-derived growth
factor (rhPDGF-BB). The
two components are mixed together before being gently packed into
the bony area that is being treated.
The β-TCP component has been used for many years to help repair bones in
the extremities (arms and legs), spine, and pelvis. It provides the
new bone cells with a framework to grow on, helps stabilize the
blood clot that forms at the injury site, and keeps tissue from
collapsing into the space, which might interfere with new bone
growth. As new bone grows, the β-TCP is gradually replaced by your
own bone. The β-TCP is
mixed with collagen to make it easier to handle and place during
surgery.
rhPDGF-BB is a synthetic copy of a protein that naturally occurs in your
body. Normally, naturally
occurring PDGF is released following injury from blood cells and
directs the body to repair itself.
The rhPDGF-BB component of Augment™ Injectable works in the
same way as the PDGF your body naturally produces.
The process used to manufacture rhPDGF-BB is a technology that uses yeast
cells to produce a purified form of the protein. The rhPDGF-BB used
in Augment™ Injectable is also used in an FDA-approved wound healing
agent that has been safely used to treat skin ulcers in diabetic
subjects.
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