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Infuse Bone Graft Wins FDA Nod for New Spine Surgery Indications
The FDA has approved additional spine surgery indications for Infuse Bone Graft. On receiving final labeling approval, the product’s developer, Medtronic, expects to begin marketing these expanded indications in early 2016. With the expanded approval, Medtronic will be able to market Infuse Bone Graft for use with certain spine implants made of polyetheretherketone (PEEK) in oblique lateral interbody fusion (OLIF) and anterior lumbar interbody fusion (ALIF) procedures.
The new indications for Infuse Bone Graft are:
- Use in OLIF51 procedures with certain sizes of the PEEK Perimeter implant at a single level from L5-S1.
- Use in OLIF25 procedures with certain sizes of the PEEK Clydesdale implant at a single level from L2-L5.
- Use in ALIF procedures with certain sizes of the PEEK Perimeter implant at a single level from L2-S1.
Infuse Bone Graft is used with certain Medtronic interbody fusion devices to treat lumbar degenerative disc disease. This condition can cause back and/or leg pain, as well as functional problems, such as tingling or numbness in the legs or buttocks or difficulty walking.
The active ingredient in Infuse Bone Graft (rhBMP-2) is a manufactured version of an endogenous protein that promotes new bone growth. During surgery, the product is applied to an absorbable collagen sponge (ACS). The ACS is a carrier to deliver the rhBMP-2 to the implant site and acts as a scaffold for the formation of new bone. The sponge will resorb, or disappear, over time.
The OLIF25 procedure helps surgeons preserve the patient’s psoas muscle when treating the L2 to L5 levels of the spine. In addition, it provides surgeons with easier access around the patient’s iliac crest, thereby allowing the placement of an implant into the disc space for anterior column support. The OLIF51 procedure provides lateral access to the L5 to S1 disc space and does not require surgeons to flip the patient from an anterior position during surgery.
Infuse Bone Graft is not indicated for use with a trans-psoas surgical approach. As with any surgery, a spinal fusion procedure with Infuse Bone Graft is not without risk. A variety of complications may occur in isolation or in combination. Additional surgery maybe needed to correct these complications.
Source: Medtronic; December 11, 2015.