This biologic device is used in spinal fusion surgery for patients with degenerative disc disease and consists of two elements:
INFUSE® Bone Graft – A bone morphogenetic protein (BMP) that stimulates the body to regrow bone that will join two vertebrae together to stabilize the spine
LT-CAGE® Device – A small, hollow metal cylinder, or cage, that holds the biologic material and restores the degenerated disc space to its original height
The importance of INFUSE Bone Graft with the LT-CAGE Device is that it:
Eliminates the need to take a bone graft from the hip of the patient, a procedure that often causes significant pain in the patient's hip.
Clinical studies of INFUSE Bone Graft with the LT-CAGE Device have resulted in the elimination of complications and pain associated with graft harvesting in 100 percent of patients, postoperatively. Please note: results may vary.
Is proven to be equal in fusion rates and level of relief with a graft from their hip (autograft), which is considered the “gold standard” of bone grafts.
Hear Ann’s experience with INFUSE® Bone Graft.
Ann found she had spondylolisthesis, a condition – congenital, in her case – where one vertebra slips over the other. She also was diagnosed with degenerative disc disease, spinal stenosis, and foraminal stenosis, all of which may result in back pain, leg numbness and loss of mobility.
This device has not been tested in pregnant women to determine if there is any effect on a developing fetus. This device has also not been studied in nursing mothers. When tested in female rabbits that received the rhBMP-2, a component of the device, developed an immune response and later became pregnant, the following was seen:
The antibodies developed by the mother were able to reach the developing rabbit fetus. The effect of these antibodies on the developing rabbit fetus is not currently known.
Some bone formation abnormalities were observed in a small number of the rabbit fetuses tested. It is not known if these changes would disappear as the rabbit fetus continued to develop or at some time after birth.
This device should not be used immediately prior to or during pregnancy. Women of child-bearing potential should be advised not to get pregnant for one year following treatment with the device. Women of child bearing potential should be warned of potential risk to a fetus and should discuss other possible orthopedic treatments with their surgeon.
BMP-2 plays a critical role during fetal development in humans and other animals. It is not known whether a pregnant woman, previously exposed to BMP-2 by implantation with the device, might develop a second immune response to BMP-2 from the developing fetus with adverse effects for the woman or baby. In a rabbit pregnancy study to investigate this issue, no increase in anti-BMP-2 antibodies was observed.