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FDA approves additional indications for Medtronic’s Infuse Bone Graft
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Medtronic announced the FDA approval of additional spine surgery indications for its Infuse Bone Graft. Upon receiving final labeling approval from the FDA, the company expects to begin marketing the expanded indications in early 2016.
According to a company press release, Medtronic will be able to market the 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 with this expanded approval. The new indications include use of the Infuse Bone Graft 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 L2-5; and use in ALIF procedures with certain sizes of the PEEK Perimeter Implant at a single level from L2-S1.
“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,” Doug King, senior vice president and president of Medtronic’s Spinal business, which is part of the Restorative Therapies Group at Medtronic, said in the release.
Reference: www.medtronic.com