With more than fifteen years of clinical history, PEEK-OPTIMA Natural polymer, is the first medical-grade PEEK used in spinal fusion surgeries. PEEK is currently the most popular biomaterial for interbody fusion, accounting for 73% of all devices used in 2016.1 Clinical studies suggest that PEEK-OPTIMA 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-OPTIMA HA Enhanced. Hydroxyapatite (HA), a well-known osteoconductive material that enhances bone apposition, is fully integrated, not coated, into the PEEK-OPTIMA matrix, making it available on all surfaces of a finished device. While offering all of the benefits of PEEK-OPTIMA Natural polymer, pre-clinical studies have demonstrated potential performance advantages when comparing against it 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
1. IMS Health, SpineMarket 2016, Minneapolis, MN.
2. Study evaluated the bone ongrowth of PEEK-OPTIMA Natural and PEEK-OPTIMA 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-OPTIMA Natural, PEEK-OPTIMA 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