3D Systems Announces FDA Clearance for World’s First 3D-Printed PEEK Cranial Implants

• FDA clearance enables wide-spread adoption of 3D Systems self-contained, cleanroom environment-based printing system, the EXT 220 MED, with medical-grade PEEK materials to deliver patient-specific cranial reconstruction solutions
• 3D-printed PEEK implants using the EXT 220 MED successfully demonstrated in nearly 40 cranioplasties across Europe in recent months
• Market for cranial reconstruction anticipated to exceed $2 billion by 2030
• FDA clearance establishes strong foundation for expanded application of these unique, cost-effective technologies to additional orthopedic surgical indications

ROCK HILL, S.C., April 15, 2024 (GLOBE NEWSWIRE) -- Today, 3D Systems (NYSE:DDD) announced 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 modeling software, the 3D Systems EXT 220 MED 3D printer, Evonik VESTAKEEP i4 3DF PEEK (polyetheretherketone), and a pre-defined production process. By utilizing additive manufacturing solutions, this technology can produce patient-specific cranial implants with up to 85% less material than similar implants produced by traditional machining, which can lead to significant cost savings for an expensive raw material like implantable PEEK. Furthermore, 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, 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.”