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|For Immediate Release:
Sinai Spine Surgeons to Offer new FDA Approved Device to Treat low Back Pain
Spine surgeons at Sinai Hospital of Baltimore now offer an innovative new device for certain types of spinal degenerative disc disease, a common cause of lower back pain. With the recent FDA approval of InFUSETM Bone Graft/LT-CAGE, a bone stimulating protein called rhBMP-2 (BMP) plus a metal fusion cage, surgeons are able to eliminate the bone graft harvesting surgery required in spine fusion procedures, often the most effective treatment option for degenerative disc disease.
Orthopedic surgeons, Alex Curcin, M.D., and Mark Rosenthal, M.D., will spearhead the use of InFUSETM Bone Graft/LT-CAGE in lumbar spine fusion surgery at Sinai Hospital's new spine center. The first surgery is scheduled for July 23, 2002. Curcin, Rosenthal, Alan Levine, M.D., another Sinai orthopedic surgeon, and Sinai's neurosurgical division will lead Sinai's spine center that will launch later this year.
Spinal fusion surgery involves "welding" two or more of the vertebrae together with bone grafts and internal devices, such as metal rods, to heal into a single solid bone with the purpose of alleviating lower back pain.
"Traditionally, spinal fusion calls for two separate surgeries: one to harvest the
patient's own bone from the pelvis for grafting purposes and a second to fuse the vertebrae together with the harvested bone. BMP eliminates the need for the bone harvesting procedure, which in studies has been shown to sometimes be more painful than the fusion itself,” said Rosenthal. "Now we can relieve patients from debilitating back pain by means of a shorter, less invasive surgical procedure that is much more patient-friendly.”
During fusion surgery, surgeons prepare the BMP, or InFUSETM Bone Graft, which comes in powder form, with sterile water and then apply it to a special carrier, which resembles a small sponge. The carrier is then inserted into a thimble-like fusion cage, the LT CAGE, and implanted between the affected vertebrae. These cages stabilize the spine while allowing the protein to leak out where needed, leading ultimately to fusion.
The official name for the biologic protein is recombinant human bone morphogenetic protein. It is a genetically engineered version of a naturally occurring protein found in human bone that stimulates bone formation and growth.
"This is a very exciting and revolutionary time in the field of spinal surgery,” said Curcin. "Though this product holds tremendous promise and opportunity, it is important that doctors receive specialized education and training in the use of BMP.” Both Curcin and Rosenthal have been specially trained and are authorized to use this FDA approved product.
"While the currently approved InFUSETM Bone Graft/LT-CAGE is indicated only
for anterior [from the front] spinal fusions, we at Sinai Hospital are involved in a nationwide multicenter study investigating the next application of BMP in posterior [from the back] spinal fusions,” said Curcin.
Degenerative disc disease occurs when one or more discs lose the ability to cushion the vertebrae due to osteoarthritis, injury, disc herniations or abnormal spinal curvatures. The result is instability of the spine, pressure on nerves and, therefore, pain. To relieve the pain, doctors eliminate the movement between the affected vertebrae by fusing them together. Studies show that by the age of 65, approximately 90 percent of the population will show signs of degenerative disc disease.
BMP is marketed under the name InFUSETM Bone Graft and has been approved by the FDA for use with the LT-CAGE Lumbar Tapered Fusion Device, a product of Medtronic Sofamor Danek.
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