A LEADING CHOICE FOR SPINAL FUSION DEVICES
Over 15 years ago, the biocompatible PEEK-OPTIMA Natural polymer quickly became the
material of choice in interbody fusion and developed a successful clinical track record. Today
approximately 9 million PEEK-OPTIMA devices are implanted worldwide. With the introduction
of PEEK-OPTIMA HA Enhanced, Invibio continues to revolutionize the spinal fusion market.
MODULUS SIMILAR TO BONE
PEEK-OPTIMA polymers are less stiff compared to metal, making it a good fit for applications where load sharing is desired to promote bone remodeling
REDUCED STRESS SHIELDING
PEEK-OPTIMA polymers help to reduce the loss of bone mass as normal stress is removed from the bone by an implant
ARTIFACT-FREE IMAGING
PEEK-OPTIMA polymers are radiolucent without imaging artifacts in X-rays, CT and MRI scans, making it a good option when unobstructed views are required to assess healing or disease progression
INTERBODY FUSION DEVICES MADE WITH PEEK-OPTIMAtm POLYMERS
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
References:
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
EVIDENCE FOR INTERBODY FUSION
VIDEO
Early Clinical Results For
Cervical And Lumbar Fusion
View the webinar presented by surgeons featuring multi-=patient case series with PEEK-OPTIMA HA Enhanced devices.
Hear about the potential patient benefits indicated by early clinical results.
VIDEO
The Next Step in Material
Development for Interbody
Fusion
Hear what surgeons are saying about PEEK-OPTIMA HA Enhanced Polymer and view results of the latest pre-clinical studies.
Reference:
1. Study evaluated the bone ongrowth of PEEK-OPTIMA 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 experience.
2. 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 has not been correlated with human clinical experience.
