SPINAL INTERBODY FUSION 

INTERBODY FUSION DEVICES MADE WITH PEEK-OPTIMA™ POLYMERS

With twenty years of clinical history, PEEK-OPTIMATM Natural polymer is the first medical-grade PEEK used in spinal fusion surgeries. PEEK is currently the most widely used biomaterial for interbody fusion, accounting for 62% of all devices used in 2018.1 Clinical studies suggest that PEEK-OPTIMATM performs as well as, or better than, interbody fusion devices made of metals or bone, while providing some distinct clinical advantages over competing biomaterials including:

  • Modulus similar to bone
  • Reduced stress shielding
  • Artifact-free imaging

Invibio continues to revolutionize the spinal fusion market with the introduction of PEEK-OPTIMATM HA Enhanced. Hydroxyapatite (HA), a well-known osteoconductive material that enhances bone apposition, is fully integrated, not coated, into the PEEK-OPTIMATM matrix, making it available on all surfaces of a finished device. While offering all of the benefits of PEEK-OPTIMATM Natural, pre-clinical studies have demonstrated potential performance advantages when comparing PEEK-OPTIMA HA Enhanced against PEEK-OPTIMA Natural including:

  • Earlier bone ongrowth with >75% direct bone contact after 4 weeks2
  • Enhanced bone apposition at 12 weeks2
  • Greater new bone formation at 6 weeks3
  • Higher quality new bone bridging at 6 and 12 weeks3
  • Bone ongrowth on the endplates and all faces of the interbody device3
  • Superior mechanical performance outperforming allograft in 46% of the instances3

Early clinical results for cervical and lumbar spinal fusion indicate potential benefits and reveal specific improvements as observed by surgeons4:

  • Solid fusions as early as 6 months
  • Dense bone apposition at the bone-implant interface
  • Positive clinical outcomes at early time points
  • Improvements in overall pain and neurological function

References

  1. IQVIA, Spinemarket Inc. 2018, Minneapolis, MN.
  2. Study evaluated the bone ongrowth of PEEK-OPTIMATM Natural and PEEK-OPTIMATM HA Enhanced in a bone defect model in sheep. Data on file at Invibio. This has not been correlated with human clinical data.
  3. Study evaluated the in vivo response to PEEK-OPTIMATM Natural, PEEK-OPTIMATM HA Enhanced and allograft in a cervical spine fusion model in sheep. Data on file at Invibio. This data has not been correlated with human clinical experience.
  4. Webinar: PEEK-OPTIMA™ HA Enhanced Devices for Cervical and Lumbar Fusion: Insights from Early Clinical Experience, presented by Timothy Bassett, MD and Brad Prybis, MD, March 2, 2017.

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