In an ongoing translational project, the first 3D printed cranioplasty implant was successfully implanted in a patient. The advantages for the patients are many. For example, operations can be done faster and the implants will be better adapted to the patient which means fewer complications.
"As far as we know this is the first time in the world where the hole process from design to manufacture was made by a hospital. The project challenges the current medical device regulatory paradigm, which is important for health care and academic researchers to continue to be innovative", says Einar Heiberg, associate professor at the Faculty of Medicine at Lund University and Clinical Fellow at the Wallenberg Centre for Molecular Medicine in Lund.
The implant was printed in the material PEEK (poly-ether-ether-ketone). This material has been used for implants for over 20 years, but it is only until recently it can be printed on medical grade 3D printers. The main challenge in the project is not technical, but rather regulatory on which documentation is required and to understand what is possible to do for as health care provider.
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