A novel cranio-maxillofacial implant technology that uses an advanced polymer biomaterial, PEEK-OPTIMA® (from Invibio Biomaterial Solutions), to extend benefits to patients with severe malformation and defects of the skull and facial region has been developed by the Maastricht University Medical Centre (MUMC+). Patient-specific cranial implants are most commonly used to treat skull defects resulting from trauma, tumors and aneurysms. The Patient Specific Implant (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 are produced on-site, using a high speed milling fabrication process. According to Maikel Beerens (B.Sc. in Medical Engineering), who initially designed and now markets IDEE’s (Instrument Development Engineering & Evaluation) patient specific implants (PSI), PEEK-OPTIMA’s material characteristics and performance properties provide real and valuable surgeon/patient benefits that include:
• Ideal biological properties very comparable to bone;
• No stress shielding;
• No conductibility of temperature;
• Separation of PEEK from surrounding bone, which ensures the initial position of the implant
• Proven biocompatibility and biostability,
• Natural radiolucency and compatibility with medical imaging to monitor site healing
“The patient’s own removed bone segments are always the first choice for implantation. However, unfortunately only a few of those re-implantations succeed, leaving the patient with a defect. To reconstruct this defect in the best way possible the surgeon uses a patient specific implant. Although the use of PEEK is relatively new in the case of cranial implants, Invibio’s PEEK-OPTIMA® is proven with over 10 years of history in a wide variety of different regulatory approved devices. Their verified biocompatibility and biostability is crucial for surgeons when choosing materials”, commented Peter Kessler (chair professor, Department of Cranio-Maxillofacial Surgery, MUMC+).