3D Systems Gets FDA Clearance for 3D-Printed Cranial Implants

FDA clearance enables adoption of 3D Systems' printing system, the EXT 220 MED, with medical-grade PEEK materials to deliver patient-specific cranial reconstruction solutions.

FDA clearance enables adoption of 3D Systems' printing system, the EXT 220 MED, with medical-grade PEEK materials to deliver patient-specific cranial reconstruction solutions.

Cranial implant. Image courtesy of 3D Systems.

3D Systems reports the U.S. 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 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 predefined production process. By using additive manufacturing solutions, this technology can reportedly produce patient-specific cranial implants with notably less material than similar implants produced by traditional machining.

The cleanroom-based architecture of the printer combined with post-processing workflows makes it a technology beneficial for producing patient-specific medical devices at the hospital site with faster turnaround, the company reports. 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.

The VSP PEEK Cranial Implant is a FDA-cleared, additively manufactured PEEK implant intended for cranioplasty procedures to restore defects in the skull. This implant-grade, high-performance polymer has biocompatibility, resistance to bodily fluids, and stability in a wide range of temperatures, making it useful for many medical device applications, according to 3D Systems. Its inherent radiolucency ensures minimal interference in medical imaging, facilitating a clearer evaluation of the surgical site and implant integrity, the company adds.

“Receiving FDA clearance for our VSP PEEK Cranial Implant solution is a significant milestone in our journey,” says Dr. Gautam Gupta, senior vice president and general manager, medical devices, 3D Systems. “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.” 

It is anticipated that the use of 3D-printed cranial implants will accelerate, according to 3D Systems, 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 roughly $1.2 billion and is anticipated to approach $2.1 billion by 2030. Cranial implants can address a breadth of applications including trauma, defects, and reconstruction.

Sources: Press materials received from the company and additional information gleaned from the company’s website.

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