3D Systems has received FDA 510(k) clearance for its 3D-printed, patient-specific cranial implant solution — VSP PEEK Cranial Implant. The workflow for the VSP PEEK Cranial Implant has also been cleared. 
 
VSP PEEK Cranial Implant is the first FDA-cleared additively manufactured PEEK implant intended for cranioplasty procedures to restore defects in the skull. PEEK has excellent biocompatibility, resistance to bodily fluids, and stability in a wide range of temperatures, making it an ideal choice for many medical device applications. 
 
The implant utilizes a high-performance polymer that has a well-known clinical history in medical device applications due to its exceptional performance closely resembling the mechanical properties of human bone. It also has radiolucency which ensures minimal interference in medical imaging, for a clearer evaluation of the surgical site and implant integrity.
 
The workflow uses segmentation and 3D modeling software, the 3D Systems EXT 220 MED 3D printer, Evonik VESTAKEEP i4 3DF PEEK (polyetheretherketone), and a pre-defined production process. This technology uses additive manufacturing solutions to produce patient-specific cranial implants with up to 85% less material than similar implants produced by traditional machining.
 
The technology of the VSP PEEK Cranial Implant creates patient-specific medical devices with a faster turnaround with significant cost savings through the cleanroom-based architecture of the printer combined with simplified post-processing workflows.
 
This solution has been used to enable nearly 40 successful cranioplasties in Switzerland at University Hospital Basel, in Austria at Salzburg University Hospital, and in Israel at Tel-Aviv Sourasky Medical Center.
 
“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 & 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 fiber-reinforced PEEK for plating applications in trauma and fixation, and bioresorbable polymers for large bone and craniomaxillofacial applications.”
 
“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.”
 
This FDA clearance enables 3D Systems to significantly expand its PEEK product portfolio through the EXT 220 MED platform.