VSP PEEK includes a complete, FDA-cleared workflow comprising segmentation and 3D modeling software. It also offers a pre-defined production process.
With its additive manufacturing capabilities, the technology can produce patient-specific cranial implants with up to 85% less material than similar implants produced by traditional machining, according to 3D Systems. The company says this leads to significant cost savings for expensive raw material like implantable PEEK.
Additionally, the clean-room-based printer architecture and simplified post-processing workflows help with faster hospital turnaround. 3D Systems says that, to date, nearly 40 successful cranioplasties took place after use of the technology. They took place in Switzerland, Austria and Israel.
“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 revolutionizing 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 customized PEEK cranial plates is significant to integrate 3D printing into routine clinical practice.”
More about the 3D Systems VSP PEEK cranial implant
3D Systems says its implant is the first FDA-cleared, additively manufactured PEEK implant for cranioplasty procedures to restore skull defects. PEEK, a high-performance polymer, offers mechanical properties that closely mirror human bone. It also offers biocompatibility, resistance to bodily fluids and stability in a range of temperatures.
Additionally, 3D Systems says PEEK has inherent radiolucency. This ensures minimal interference in medical imaging, facilitating a clearer evaluation of the surgical site and implant integrity.
The company says FDA clearance allows it to expand its PEEK product portfolio through the EXT 220 MED printer platform. It said the introduction of VSP PEEK sets the stage for a range of PEEK based solutions for the medical field. Future applications could include 3D-printed spine interbody fusion implants, carbon fiber-reinforced PEEK for plating applications in trauma and fixation, and bioresorbable polymers for large bone and craniomaxillofacial applications.
“As a leader in medical device innovation, 3D Systems prides itself on pioneering advancements that benefit both surgeons and patients,” said Dr. Gautam Gupta, SVP & GM, medical devices, 3D Systems. “Receiving FDA clearance for our VSP PEEK Cranial Implant solution is a significant milestone in our journey.
“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.”
