CRANIO-MAXILLOFACIAL

PEEK-OPTIMATM polymer is paving the way in cranio-maxillofacial (CMF) implant technology enabling radiolucency, anatomic adaptation with high stability, and no effect on tissue1

Patient-Specific Implants (PSIs) made with PEEK-OPTIMATM Natural may extend the range of patient and surgeon benefits beyond those of medical-grade titanium; the traditional biomaterial used for cranio-maxillofacial (CMF) PSIs. The trend of using PEEK-OPTIMA for patient-specific implant technology continues due to the need for larger repairs with a high degree of complexity.

PEEK-OPTIMA PSIs for cranioplasty offer many advantages over other cranioplasty materials such as titanium and PMMA (Poly(methyl methacrylate).  PEEK-OPTIMA Natural is:

  • Highly compatible with CAD/CAM milling processes, resulting in more precise implant fixation, while allowing intra-operative fine-tuning of contours2   
  • Strong, a clear advantage especially in the frontal bone region which is prone to impact3-5   
  • Bio-inert and biocompatible1,8
  • Naturally radiolucent and compatible with CT and MR imaging modalities, allowing post-operative diagnostic imaging, which is particularly important in oncology cases 2,7,8   

With applications such as the PEEK Custom Skull Implant (CSI) by Kelyniam Global, Inc., this disruptive 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.9

Maastricht University Medical Centre (MUMC+) has developed a novel cranio-maxillofacial (CMF) implant technology that uses our advanced PEEK-OPTIMA Natural polymer. This PEEK-OPTIMA derived PSI technology extends the range of patient/surgeon benefits beyond those of medical-grade titanium. The MUMC+ process uses CAD software to design the PSI to the individual CMF contours of the patient.10

NEOS Cranial LOOP™ from NEOS Surgery™ is the first 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 the 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 radiolucent CT/MR imaging without scattering or artifact) 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, instrument-free fixation devices. Its unique design and materials allow it to perfectly adapt to the epi-cranial and sub-cranial shape and curvature.11

References:

1. Data on file at Invibio.

2. Hanasono MM, et al. Calvarial Reconstruction With Polyetheretherketone Implants. Ann Plast Surg. 2009 Jun;62(6):653-5.

3. Lethaus B. et al. Cranioplasty with Customized Titanium and PEEK Implants in a Mechanical Stress Model. J Neurotrauma. 2012 Apr 10;29(6):1077-83.

4. Scolozzi P. et al. Complex Orbito-fronto-Temporal Reconstruction Using Computer-Designed PEEK Implant. J Craniofac Surg. 2007 Jan;18(1):224-8.

5. Garcia-Gonzalez D. et al. On the mechanical behaviour of PEEK and HA cranial implants under impact loading. J Mech Behav Biomed Mater. 2017 May;69:342-354.

6. Toth JM. Biocompatibility of Polyaryletheretherketone Polymers. In: Kurtz, SM. ed. PEEK Biomaterials Handbook First Edition. Oxford: William Andrew Publishing, 75-79.

7. Green S. Compounds and Composite Materials. In: Kurtz, SM. ed. PEEK Biomaterials Handbook First Edition. Oxford: William Andrew Publishing, 75-79.

8. Cabraja M. et al. Long-term results following titanium cranioplasty of large skull defects. Neurosurg Focus. 2009 Jun;26(6):E10.

9. Invibio PEEK-OPTIMATM polymer to be used in Commercially-Available Custom Skull Implants.

10. 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.

11. NEOS uses PEEK-OPTIMA To “Re-invent” Cranial Fixation.

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