CRANIO-MAXILLOFACIAL

Our biomaterials are paving the way in cranio-maxillofacial implant technology enabling radiolucency, anatomic adaptation with high stability, and no effect on tissue…

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.

• The material is eminently compatible with CAD/CAM milling processes, resulting in more precise implant fixation whilst allowing intra-operative fine-tuning of contours ¹
• Its strength is a clear advantage, especially in the frontal bone region which is prone to impact^2-4
• PEEK-OPTIMA™ Natural is bio-inert and biocompatible^7,8
• It’s natural radiolucency and compatibility with CT and MR imaging modalities allows post-operative diagnostic imaging, which is particularly important in oncology cases^1,9,10

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 Solutions. 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

REFERENCES:

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 Invibio
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-OPTIMA 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