PEEK-OPTIMA™ Natural polymer derived Patient-Specific Implants (PSI) technology extends the range of patient and surgeon benefits beyond those of medical-grade titanium; the traditional biomaterial used for cranio-maxillofacial PSIs. It continues the trend of using PEEK-OPTIMA™ within patient-specific implants due to the desire for larger repairs with a high degree of complexity.
PEEK-OPTIMA™ PSI for cranioplasty offer many advantages over other cranioplasty materials such as Titanium and PMMA.
Our biomaterials are paving the way in cranio-maxillofacial implant technology with applications such as the PEEK Custom Skull Implants by Kelyniam Global, Inc. This disrupting technology relies on the strength, bone-like modulus, radiolucency, purity, versatility and guaranteed supply of our high quality PEEK-OPTIMA™ polymer. The Kelyniam CSI is intended to correct or replace bony voids in the cranial skeleton caused by trauma or birth defects while promoting a better anatomic fit versus conventional reconstruction methods and materials.11
Maastricht University Medical Centre (MUMC+) has developed a novel cranio-maxillofacial implant technology that uses our advanced polymer biomaterial, PEEK-OPTIMA™polymer, from Invibio Biomaterial SolutionsTM. This PEEK-OPTIMA™ derived PSI technology extends the range of patient/surgeon benefits beyond those of medical-grade titanium, the traditional biomaterial used for cranio-maxillofacial PSIs. The MUMC+ process uses CAD software to design the PSI to the individual cranio-maxillofacial contours of the patient. The customized implants was co-developed by Maastricht University Medical Centre’s engineering department IDEE (Instrument Development Engineering & Evaluation), the Department of Cranio-Maxillofacial Surgery and Maastricht Instruments (MI) and spun out into Xilloc Medical B.V.12
NEOS Cranial LOOP™ from NEOS Surgery™ is the first-ever cranial fixation device made entirely of PEEK-OPTIMA™ polymer. The result of extensive research and development, the Cranial LOOP is a game-changing addition to NEOS’ line of innovative cranial fixation devices. The instrument-free design is made possible by PEEK-OPTIMA™ material characteristics (including high elastic modulus, high tensile strength, and highly radiolucent CT/MRI imaging without scattering or artifacts) and incorporates a self-cutting function for removing the non-implantable part of the device. A fast and easy “pull and tighten” action allows the surgeon to control and feel the fixation; a standard bone flap with three Cranial LOOPs can be fixated in less than a minute. The NEOS Cranial LOOP produces fixation strengths similar to those of other standard metallic, non instrument-free fixation devices. Its unique design and materials allow it to perfectly adapt to the epicranial and subcranial shape and curvature.13
1. Hanasono, M.M. et al., (2009). Calvarial Reconstruction With Polyetheretherketone Implants. Annals of Plastic Surgery, 62(6), 653-655
2. Lethaus, B. et al., (2012). Cranioplasty with Customized Titanium and PEEK Implants in a Mechanical Stress Model. Journal of Neurotrauma, 29(6), 1077-1083
3. Scolozzi, P. et al., (2007). Complex orbito-fronto-temporal reconstruction using computer-designed PEEK implant. Journal of Craniofacial Surgery, 18(1), 224-228.
4. Garcia-Gonzales, D. et al., (2017). On the mechanical behaviour of PEEK and HA cranial implants under impact loading. Journal of the Mechanical Behavior of Biomedical Materials, 69, 342-354
5. Kim, M.M. et al., (2009). Use of customized polyetheretherketone (PEEK) implants in the reconstruction of complex maxillofacial defects. Archives of Facial Plastic Surgery, 11(1), 53-57
6. Zanotti, B. et al., (2016). Cranioplasty: Review of Materials. Journal of Craniofacial Surgery, 27(8), 2061-2072
7. Data on file at InvibioTM
8. Toth, JM. Biocompatibility of Polyaryletheretherketone Polymers. In : Kurtz, SM., ed. PEEK biomaterials handbook. Oxford : William Andrew Publishing, 75-79
9. Green, S. Compounds and Composite Materials. In : Kurtz, SM., ed. PEEK biomaterials handbook. Oxford : William Andrew Publishing, 75-79
10. Cabraja, M. et al., (2009). Long-term results following titanium cranioplasty of large skull defects. Neurosurgical Focus, 26(6), E10
11. Invibio PEEK-OPTIMATM polymer to be used in Commercially-Available Custom Skull Implants
12. The novel cranio-maxillofacial implant technology was co-developed by Maastricht University Medical Centre’s engineering department IDEE (Instrument Development Engineering & Evaluation), the Department of Cranio-Maxillofacial Surgery and Maastricht Instruments (MI) and spin out into Xilloc Medical B.V.
13. NEOS uses PEEK-OPTIMA To “Re-invent” Cranial Fixation
Interbody Fusion devices made with PEEK-OPTIMA HA Enhanced are now being used to treat patients who require cervical and lumbar fusion. Review the case series presentations and learn what surgeons have observed