The FDA approved Medtronic's Infuse Bone Graft for use with additional polyetheretherketone spine implants in oblique lateral interbody fusion and anterior lumbar interbody fusion procedures at a single level.
Here are five notes.
1. This is the second expanded indication in a little over two years.
2. The new approved indications are: use in OLIF 51 procedures with Divergence-L Interbody Fusion Device at a single level from L5-S1; use in OLIF 25 procedures with Pivox Oblique Lateral Spine System at a single level from L2-L5; and use in ALIF procedures with Divergence-L Interbody Fusion Device at a single level from L2-S1.
3. Infuse Bone Graft is used with certain Medtronic interbody fusion devices to treat lumbar degenerative disc disease, which can cause back and/or leg pain, tingling or numbness in the legs or buttocks, or difficulty walking.
4. On the market since 2002, Infuse Bone Graft is approved for certain spine, oral-maxillofacial and orthopedic trauma surgeries.
5. A manufactured version of a body's protein that promotes new bone growth called rhBMP-2 is the active ingredient in Infuse Bone Graft.