FDA Approval for 3D Systems' VSP PEEK Cranial Implants Revolutionizes Neurosurgery
In April 2024, Xpiens learned that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance to 3D Systems for its groundbreaking VSP PEEK cranial implant solution. This fully FDA-approved workflow includes segmentation and 3D modeling software, the 3D Systems EXT 220 MED 3D printer, Evonik VESTAKEEP i4 3DF PEEK material, and a predefined production process.
Innovative Manufacturing Saves Cost
By harnessing additive manufacturing solutions, the production of patient-specific cranial implants uses up to 85% less material compared to traditional manufacturing processes. This significant reduction not only saves costs but also optimizes the use of expensive raw materials like PEEK.
Ideal for On-Site Hospital Manufacturing
The combination of a cleanroom environment and simplified post-processing workflows makes this printer an ideal technology for producing patient-specific medical devices directly at hospital sites. This capability significantly speeds up turnaround times while controlling overall costs.
Proven Success in Leading Hospitals
To date, the cranial implant solution has been successfully implemented in nearly 40 cranial surgeries at leading medical institutions across Europe, including University Hospital Basel in Switzerland, Salzburg University Hospital in Austria, and Sourasky Medical Center in Tel Aviv, Israel. Dr. Johannes Pöppe, a senior neurosurgeon at Salzburg University Hospital, remarked, “The 3D printed PEEK cranial plates are a transformative solution that enhances patient care and expands the possibilities for precise, personalized neurosurgical procedures.”
FDA-Approved Material with Excellent Properties
The VSP PEEK cranial implant is the first FDA-approved additive manufactured PEEK implant for cranial reconstruction to repair cranial defects. Known for its superior performance and mechanical properties closely matching human bone, PEEK is also biocompatible, fluid-resistant, and stable across a wide temperature range. Its inherent radiolucency minimizes interference with medical imaging, aiding in the clearer evaluation of surgical sites and implant integrity.
A Milestone in Medical Device Innovation
Dr. Gautam Gupta, Vice President and General Manager of Medical Devices at 3D Systems, stated, “As leaders in the field of medical device innovation, we are proud of the groundbreaking progress that benefits surgeons and patients alike. The FDA approval of our VSP PEEK cranial implant solution marks a significant milestone in our development. With this approval, we are setting new standards for surgery in the U.S. and continuing to explore the next applications of this technology.”
