3D Systems
The FDA has provided 3D Systems with 510(k) clearance for its 3D printed and patient-specific VSP PEEK Cranial Implant.
The VSP PEEK Cranial Implant solution includes a complete workflow comprising segmentation and 3D modelling software, the 3D Systems EXT 220 MED 3D printer, Evonik VESTAKEEP i4 3DF PEEK and a pre-defined production process.
Having been cleared by the FDA, healthcare providers can now confidently implement the VSP PEEK Cranial Implant, saving up to 85% less material than similar implants produced by traditional machining and delivering ‘significant’ cost savings according to 3D Systems.
To date, this solution is said to have been used to enable nearly 40 successful cranioplasties in Switzerland at University Hospital Basel, Salzburg University Hospital, and at Tel-Aviv Sourasky Medical Center. In these procedures, the VSP PEEK Cranial Implant has been used to restore defects in the skull. Thanks to the PEEK material used to produce the implant, it has excellent biocompatibility, resistance to bodily fluids, stability in a wide range of temperatures, and has mechanical properties that closely mirror human bone. Additionally, its inherent radiolucency ensures minimal interference in medical imaging, facilitating a clearer evaluation of the surgical site and implant integrity.
“3D-printed PEEK cranial plates are an innovative solution that can improve patient care and expand the possibilities for precise, individualized neurosurgery,” said Dr. Johannes Pöppe, Senior Attending Surgeon, Department of Neurosurgery, University Hospital Salzburg. “The solution is revolutionising the field. The combination of 3D Systems’ printing technology that is uniquely engineered for sterile environments along with the mechanical properties of PEEK are helping surgeons push boundaries. Within our hospital, we have already completed several successful surgeries using these technologies. I believe the potential for customised PEEK cranial plates is significant to integrate 3D printing into routine clinical practice.”
“As a leader in medical device innovation, 3D Systems prides itself on pioneering advancements that benefit both surgeons and patients,” added Dr. Gautam Gupta, SVP & General Manager, Medical Devices, 3D Systems. “Receiving FDA clearance for our VSP PEEK Cranial Implant solution is a significant milestone in our journey. Our EXT 220 MED printing system has already enabled the production of nearly 40 cranial implants in support of successful cranioplasties throughout Europe. With this FDA clearance, we are now able to bring VSP PEEK Cranial Implant to the U.S. — setting a new standard of excellence for these procedures. We are now looking to the next applications for this technology, which includes 3D-printed spine interbody fusion implants, carbon fibre-reinforced PEEK for plating applications in trauma and fixation, and bioresorbable polymers for large bone and craniomaxillofacial applications.”
3D Systems says the FDA clearance of its VSP PEEK Cranial Implant solution ‘sets the stage’ for a ‘comprehensive range’ of advanced PEEK-based medical solutions. The company has also previously received FDA clearance for its NextDent Base dental resin, bolus device for radiotherapy treatment, and maxillofacial surgical guides, among other products.
