Updated on 14 December 2015
Infuse Bone Graft is used with certain Medtronic interbody fusion devices to treat lumbar degenerative disc disease
Medtronic has announced the US Food and Drug Administration (US FDA) approval of additional spine surgery indications for Infuse Bone Graft. Upon receiving final labeling approval from the FDA, the company expects to begin marketing these expanded indications in early calendar year 2016.
With this 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(TM) Procedures with certain sizes of the PEEK Perimeter Implant at a single level from L5-S1.
Use in OLIF25(TM) 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.
"With these expanded indications, we can bring the benefits of this important technology to more patients to help ensure they achieve a solid fusion and the best potential for a positive clinical outcome," said Mr Doug King, senior vice president and president of Medtronic's Spinal business, which is part of the Restorative Therapies Group at Medtronic. "We believe in the safety and effectiveness of Infuse Bone Graft and reiterate our continued commitment to the product."