FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
|T02-28||Media Inquiries: 301-827-6242|
|July 2, 2002||Consumer Inquiries: 888-INFO-FDA|
FDA today approved the InFUSE Bone Graft/LT-CAGE lumbar tapered fusion device to be used in the lower region of the spine as a treatment for degenerative disc disease, a significant cause of back pain that plagues many adults.
The device consists of three components split among two parts: a metallic tapered spinal fusion cage (known as the LT-CAGE lumbar tapered fusion device) and a bone graft substitute (known as the InFUSE Bone Graft). The InFUSE Bone Graft consists of a genetically engineered human protein (rhBMP-2) and a carrier/scaffold for the protein (manufactured from bovine [cow] Type 1 collagen) that are placed inside the fusion cage.
The fusion cage maintains the spacing and temporarily stabilizes the diseased region of the spine, while the InFUSE Bone Graft is used to form bone that would permanently stabilize (fuse) this portion of the spine.
The InFUSE Bone Graft component is used instead of the patient's own bone (autograft bone). Device labeling explicitly states that the components are only to be used as a single system and that the InFUSE Bone Graft should not be used alone for this or other purposes.
FDA based its decision to approve the InFUSE Bone Graft/LT-CAGE lumbar tapered fusion device on the results of a clinical study that demonstrated the use of this device is safe and effective for promoting spinal fusion. The study also showed that the device is as safe and as effective as the same fusion cage component filled with the autograft bone. Both the InFUSE Bone Graft/LT-CAGE device and the same fusion cage component filled with the autograft bone produced fusion in approximately 90% of patients.
The study was performed at multiple sites and consisted of a randomized arm which included 143 patients who were given the InFUSE Bone Graft/LT-CAGE device and 136 patients who were treated with the cage and standard bone graft. Another 134 patients were enrolled in a non-randomized study arm and also received the new device. The primary study endpoint was the rate of spinal fusion at 24 months.
The InFUSE Bone Graft/LT-CAGE lumbar tapered fusion device should not be used if patients are pregnant or are suspected to be pregnant since potential adverse effects of the genetically engineered human protein (rhBMP-2) on a developing fetus are currently not well understood.
The other risks associated with the use of the device are those normally associated with spinal surgery, which were not seen in greater numbers than expected in the clinical trial, and the potential for exuberant bone formation. The manufacturer of the device, Medtronic Sofamor Danek, of Memphis, Tenn., will monitor for any long-term immunological or other side effects that may be associated with the use of the device.
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