3D Systems
3D Systems has announced that the Food and Drug Administration (FDA) has provided 510(k) clearance for its 3D printed, patient-specific cranial implant solution, VSP PEEK Cranial Implant.
VSP PEEK Cranial Implant includes a complete FDA-cleared workflow comprising segmentation and 3D modelling software, the 3D Systems EST 220 MED 3D printer, Evonik VESTAKEEP i4 3DF PEEK (polyetheretherketone), and a pre-defined production process.
By utilising additive manufacturing solutions, this technology can produce patient-specific cranial implants with up to 85% less material than similar implants produced by traditional machining, according to 3D Systems, which can lead to ‘significant’ cost savings for an expensive raw material such as implantable PEEK.
The company says that the cleanroom-based architecture of the printer combined with simplified post-processing workflows makes it an ideal technology for producing patient-specific medical devices at the hospital site with faster turnaround while keeping the overall cost under control.
To date, 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.
“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 in the Department of Neurosurgery at University Hospital Salzburg.
Dr. Pöppe continued: “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.”
Read more: 3D Systems cranial implant used in University Hospital Basel procedure
The VSP PEEK Cranial Implant is the first FDA-cleared, additively manufactured PEEK implant intended for cranioplasty procedures to restore defects in the skull according to the company.
The implant-grade, high-performance polymer has a ‘well-known’ history in medical device applications says 3D Systems, due to its performance with mechanical properties closely mirroring human bone. PEEK also has high levels of biocompatibility, resistance to bodily fluids, and stability in a wide range of temperatures. The company says that its inherent radiolucency ensures minimal interference in medical imaging, which facilitates a clearer evaluation of the surgical site and implant integrity.
“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 Systems says this FDA clearance enables 3D Systems to expand its PEEK product portfolio through the EXT 220 MED platform. With this milestone, the company says it is setting the stage for a comprehensive range of advanced PEEK-based solutions designed to meet the needs of the medical field.
3D Systems says it is anticipated that the use of 3D printed cranial implants will accelerate based on the availability of advanced technologies. According to a report by Acumen Research and Consulting in February 2023, the cranial implants market size in 2021 was around 1.2 billion USD, and is anticipated to approach 2.1 billion by 2030.
