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| Content Provider | IEEE Xplore Digital Library |
|---|---|
| Author | McKay, B. |
| Copyright Year | 2009 |
| Description | Author affiliation: Biologics Research and Development of Medtronic Sofamor Danek. 1800 Pyramid Place, Memphis, TN 38132 (McKay, B.) |
| Abstract | Local delivery of recombinant human bone morphogenetic protein-2 (rhBMP-2) as a bone graft substitute in spinal fusion was Food and Drug Administration approved on July 2, 2002. Its commercial trade name is INFUSE Bone Graft. It was cleared as a combination biologic device after petitioning the FDA in the early 1990s with the argument that rhBMP-2's effects were only local and not systemic. The protein is applied to a type I collagen sponge at the time of surgery. After a minimum of 15 minutes to allow binding, the collagen sponge is rolled up and placed into a titanium spinal fusion cage. Two of the rhBMP-2 loaded cages are implanted into an intervertebral spinal disc space to promote bone growth across the disc, i.e., spinal fusion. Fusion stops motion at the treated level and ultimately reduces back pain originating from the degenerated disc. This same product was FDA approved for a tibia long bone fresh fracture bone grafting application in August 2004, and for sinus elevation and alveolar defects associated with extraction sockets in March 2007. In addition, a new carrier is under clinical evaluation that will offer longer rhBMP-2 sustained release and compression resistance, further expanding the clinical utility of rhBMP-2. |
| Starting Page | 236 |
| Ending Page | 237 |
| File Size | 315701 |
| Page Count | 2 |
| File Format | |
| ISBN | 9781424432967 |
| ISSN | 1557170X |
| DOI | 10.1109/IEMBS.2009.5332518 |
| Language | English |
| Publisher | Institute of Electrical and Electronics Engineers, Inc. (IEEE) |
| Publisher Date | 2009-09-03 |
| Publisher Place | USA |
| Access Restriction | Subscribed |
| Rights Holder | Institute of Electrical and Electronics Engineers, Inc. (IEEE) |
| Subject Keyword | Humans Bones Proteins Clinical trials Surgery Pain USA Councils Shape Surges Stem cells |
| Content Type | Text |
| Resource Type | Article |
| Subject | Signal Processing Biomedical Engineering Health Informatics Computer Vision and Pattern Recognition |
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