FDA approves Infuse bone graft for three new spinal surgery indications

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The US Food and Drug Administration (FDA) has granted approval for three new spinal surgery indications for Medtronic’s Infuse bone graft. Medtronic intends to begin marketing for these new indications in early 2016.

The new indications approve Infuse for use with certain spine implants made with polyetheretherketone (PEEK) for 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.

 

Peter Whang, an associate professor in the Department of Orthopaedics at the Yale School of Medicine in New Haven, USA, says, “I believe that the proven osteoinductive properties of Infuse Bone Graft are particularly beneficial when used in conjunction with PEEK interbody spacers and the less invasive OLIF technique.”

Infuse Bone Graft is FDA-approved for certain spine, oral-maxillofacial and orthopedic trauma surgeries, but is not indicated for use with a trans-psoas surgical approach.

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