PEEK Cranial Implant Debuts at MD&M

Significant advances in implant technology will be among the highlights of the Medical Design & Manufacturing Show in Anaheim, CA Feb. 8-10.

In one of the leading examples, EOS will be showing the first PEEK craniofacial test implants to be produced with laser-sintering.

The test implants were fabricated in Germany using the EOSINT P 800 system, which is the first laser-sintering system worldwide operating at up to 385C for processing high-performance polymers.

According to EOS, high-temperature, biocompatible PEEK (polyaryletherketone) material is increasingly being used as an alternative to titanium for craniofacial implants (produced from CT-scan geometry) for patients with head injuries or congenital deformities.

"Conventional manufacturing technology can't produce patient-customized craniofacial implants, either titanium or PEEK, as economically or in as short a time span as laser-sintering," says Joerg Lenz, collaborative projects coordinator for EOS with a European Union-funded project called Custom-IMD. "What's more, EOS technology has enabled us to develop a specific geometry that can only be realized using additive manufacturing. This new design incorporates a mesh scaffold that promotes improved bone growth and optimizes infiltration with a hydroxyapatite-filled, bio-absorbable polymer."

The final test implant is filled with bio-absorbable SupraB/hydroxyapatite compound. Hydroxyapatite is a calcium phosphate ceramic that is chemically similar to the mineral component of bone and will support bone growth.

Coatings of hydroxyapatite are often applied to titanium or stainless steel implants to improve surface properties.

SupraB is a polymer based on 2-ureido-4[1H]- pyrimidinones.

EOS will be showing an implant filled with the compound at MD&M. It was designed by a team at AZM (the University Hospital Maastricht, The Netherlands) headed by Dr. Jules Poukens. A patent for the network of holes in the unique mesh scaffold has been submitted.

Lenz said he will disclose the first validated in vivo (animal) results for laser-sintered PEEK at an MD&M conference session. Human trials are planned for the future.

Lenz serves on a number of international standardization organizations, including ASTM Committee F42 on additive manufacturing technologies.

The purpose of the EU program is to develop fully customized implants that are deliverable within two days and designed solely on the clinical needs of the patient using enhanced rapid manufacturing technologies. A focal point is development of advanced biomaterials.

Selective laser sintering refers to an additive manufacturing technology in which a high-powered laser driven by a CAD file fuses tiny particles of metal or plastic in incremental layers.