Craniomaxillofacial Implants

PEEK-OPTIMA^TM 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-OPTIMA^TMNatural 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 impact^3-5
Bio-inert and biocompatible^1,8
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-OPTIMA^TM 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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Applications

Supporting the medical industry for two decades, our PEEK-OPTIMA™ polymer solutions are proven across a range of specialty applications