Oxford Performance Materials
Amongst all the scaremongering that the public are about to 3D print their own personal Armageddon, you occasionally find some 3D printing news that amazes. The 3D printing of anatomically accurate skull implants is one of those times.
Currently, to make a titanium skull implant, like the one used for heroic Pakistani teen activist Malala Yousafzai, a surgeon would shape an accurate depiction of the trauma using an MRI scan and 3D modelling software. A sheet of titanium would then be placed in a traditional mould, this mould would be revisited over a period of one to two weeks, being adjusted, cut down and modified by hand until the implant is a correct fit.
With Oxford Performance Materials’ (OPM) OsteoFab process that procedure would be dramatically shortened, doing away with the moulding and constant hand modification process. A perfectly formed implant would be 3D printed right from the MRI scan, potentially saving unimaginable sums of money, time and, more importantly, lives.
The implants are produced using PEKK polymer, an ultra high performance polymer used in biomedical implants and other highly demanding applications. Tests by Timothy Ganey, Ph.D found that compared to Titanium, greater activity per cell was achieved with the PEKK material at 10 days with fewer cells, meaning PEKK stimulates bone growth and osteointegration
With all of that in mind it is big news that the OsteoFab Patient Specific Cranial Device has received FDA 510(K) approval. The Food and Drugs Administration (FDA) approval of this device marks the first approval for an additively manufactured polymer implant.
This is the kind of thing this technology was designed for, the ability to genuinely help human lives. This is the sort of news we love to see here at Personalize.