3D Systems Receives FDA Clearance for 3D Printed VSP PEEK Cranial Implants

In the realm of cranial reconstruction, conventional methods have often relied on standardized or manually crafted implants, limiting customization and posing potential complications. However, in a breakthrough for personalized medicine, 3D Systems has recently secured FDA clearance for the world’s first 3D printed VSP PEEK Cranial Implant. This solution represents a significant leap forward in cranial reconstruction, and is expected to offer improved levels of patient-specific care.

The VSP PEEK Cranial Implant offers a complete FDA-cleared workflow, integrating segmentation and 3D modeling software with the 3D Systems EST 220 MED 3D printer and Evonik VESTAKEEP i4 3DF PEEK material. Through 3D printing, this technology crafts patient-specific cranial implants using up to 85% less material than traditional machining methods, resulting in significant cost reductions and quicker production times.

PEEK Cranial Implant placed directly onto the top of the skull.

The benefits extend beyond cost-efficiency, reports 3D Systems. The printer’s cleanroom environment, paired with streamlined post-processing, allows for on-site production of these custom implants directly at hospitals. This eliminates logistical hurdles and potentially reduces wait times for patients in need. Notably, this innovative system has already seen success in Europe and the Middle East, with just under 40 successful cranioplasties performed in Switzerland, Austria, and Israel.