The FDA approval 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
US FDA approves the VSP PEEK Cranial Implant. (Credit: 3D Systems Inc.)
3D Systems has received the US Food and Drug Administration (FDA) 510(k) approval for its 3D-printed, patient-specific cranial implant solution, VSP PEEK Cranial Implant.
The US-based 3D printing company has developed the VSP PEEK Cranial Implant using a complete FDA-approved workflow, including segmentation and 3D modelling software.
The implant was produced on the company’s EXT 220 MED 3D printer, Evonik VESTAKEEP i4 3DF PEEK (polyetheretherketone), using a pre-defined production process.
3D Systems said that by using additive manufacturing solutions, it can produce patient-specific cranial implants with up to 85% less material than traditional machining.
Also, the cleanroom-based architecture of its printer, and simplified post-processing workflows will allow producing patient-specific medical devices at the hospital site with faster turnaround.
Its cranial implant solution has been used in nearly 40 cranioplasties in Switzerland, Austria, and Israel, said the 3D printing company.
3D Systems medical devices SVP and general manager Gautam Gupta said: “As a leader in medical device innovation, 3D Systems prides itself on pioneering advancements that benefit both surgeons and patients.
“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 fibre-reinforced PEEK for plating applications in trauma and fixation, and bioresorbable polymers for large bone and craniomaxillofacial applications.”
According to 3D Systems, the VSP PEEK Cranial Implant is the first FDA-approved, additively manufactured PEEK implant intended for cranioplasty procedures to restore defects in the skull.
The implant-grade, high-performance polymer has a clinical history in medical device applications due to its superior performance with properties close to human bone.
PEEK has enhanced biocompatibility, resistance to bodily fluids, and stability in a wide range of temperatures, making it an ideal choice for many medical device applications.
Also, its inherent radiolucency enables minimal interference in medical imaging, and facilitates a clear evaluation of the surgical site and implant integrity, said the company.
Furthermore, 3D Systems said that the FDA approval supports the expansion of its PEEK product portfolio through the EXT 220 MED platform.