Medtronic Gains FDA Approval for INFUSE with Additional PEEK Implants

By Julie A. Vetalice

Medtronic gained FDA approval for use of Infuse™ Bone Graft with additional PEEK-based implants in oblique lateral and anterior lumbar interbody fusion procedures at one level. This is the second expanded indication in just over two years, following use with Clydesdale and Perimeter devices in 2015.

The newly-approved indications for InfuseBone Graft 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.
  • Use in ALIF procedures with Divergence-L Interbody Fusion Device at a single level from L2-S1.

Infuse rhBMP-2 has been on the market since 2002 and used in more than one million patients worldwide.

Sources: Medtronic; ORTHOWORLD Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory