|INFUSE™ Bone Graft|
Lumbar fusions can yield unpredictable results. With the problems that autograft presents-inconsistent quality, complications at the harvest site-there is simply no assurance of success. Not for surgeon, not for patients.
INFUSE™ Bone Graft with the LT-CAGE™
Lumbar Tapered Fusion Device, industry leader Medtronic Sofamor
Danek has altered-permanently-the landscape of spinal fusion technology.
Studied under extensive clinical trials, INFUSE™ Bone Graft and
the LT-CAGE™ Device consistently achieved rates of fusion and
recovery equivalent to autograft. And because it contains the only bone
morphogenetic protein approved for spinal fusion, INFUSE™ Bone
Graft requires no autograft. With one surgery site instead of two, patients
need less healing and suffer less.
In pre-clinical studies,
using the proven rhBMP-2 concentration and carrier combination,
the rate of bridging bone through the cages was superior.
The decisive factor:
In contrast INFUSE™
Bone Graft/LT-CAGE™ Device has been shown to grow new bone in
nonbony sites, all by itself. By virtue of its undisputed osteoinductive
capabilities, INFUSE™ Bone Graft/LT-CAGE™ Device is widely
heralded as a pivotal introduction to the field of spinal fusion technology.
In fact, the grafting protein
in INFUSE™ Bone Graft is pure BMP.
For larger defects, osteoconductive
materials are generally considered minimally effective.
The osteoinductive activity of BMPs has exciting implications in lumbar spinal fusion procedures. BMPs initiate a complex multistage cascade of events in promoting in vivo bone formation. BMPs have been shown in both in vivo and in vitro studies to induce chemotaxis (stimulation of cell migration in response to a chemical signal), and cell proliferation. A significant amount of the research on BMPs has been performed to elucidate the effects of individual BMPs at a cellular level.
One of the first steps in bone formation is the migration of mesenchymal stem cells, osteoprogenitor cells, and osteoblasts to the area. These cells respond to chemical signals that are normally released in response to bone injury. rhBMP-2 can contribute to this influx of cells since it has been shown in vitro to have chemotactic properties for stromal osteoblasts and mature osteoblasts.
As the cells migrate into the area, they begin to proliferate. This proliferation can be enhanced by mitogenic factors present at the site of injury or graft site.
Creation of INFUSE™
Following its identification and isolation, the BMP-2 gene was inserted into the chromosome of a special type of mammalian production cell. This process is called recombination. These cells will then produce rhBMP-2, because the information provided in the BMP-2 gene is transcribed into the m-RNA and the m-RNA translated into proteins by the genetic and metabolic machinery of the mammalian production cell. The production cells are allowed to grow and multiply. The BMP-2 gene that was spliced into the production cell DNA is copied each time a production cell divides. Each new production cell is able to produce rhBMP-2 (the protein in INFUSE™ Bone Graft).
Other advantages surfaced as well. The INFUSE™ Bone Graft/LT-CAGE™ Device group lost significantly less blood than autograft recipients. Operating times were shorter. And most notably, though statistically equivalent, rates of fusion were 94.5% in the INFUSE™ group and 88.7% in the autograft group at 24 months.
INFUSE™ Bone Graft/LT-CAGE™ Device patients showed a slightly higher though statistically equivalent average fusion rate than autograft control group.
From CT reconstructions, INFUSE™ Bone Graft/LT-CAGE™ Device patients exhibited new bone growth.
Operating times and blood loss were reduced for INFUSE™ Bone Graft/LT-CAGE™ Device open patients as compared to control patients.
INFUSE™ Bone Graft/LT-CAGE™ Device eliminated pain and complications relating to bone harvest.
All new bone growth was within the margins of the disc space.
In preclinical studies, INFUSE™ Bone Graft/LT-CAGE™ Device proved 100% safe and effective in lower species before higher order testing commenced.
with Absorbable Collagen Sponge
The carrier for INFUSE™ Bone Graft used in the interbody fusion studies was Type I bovine absorbable collagen sponge (ACS). This cohesive sponge is hydrated with INFUSE™ Bone Graft solution at the time of surgery. The INFUSE™ Bone Graft binds to the collagen sponge, which is then rolled and placed into the interbody device cavity.
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