The FDA has paved the way for the widespread adoption of advanced printing technology with the approval of a customized 3D-printed solution tailored to fit individual patient's skulls. This recent clearance marks a significant milestone in medical innovation.
A sign for the Food And Drug Administration is seen outside the headquarters on July 20, 2020, in White Oak, Maryland. (Photo: Sarah Silbiger/Getty Images)
Approving 3D-Printed Cranial Implants for US Entry
The Food and Drug Administration (FDA) has made history by approving the entry of 3D-printed cranial implants into the US market. This groundbreaking decision follows the successful use of these implants in over 40 cranioplasty surgeries in Switzerland, Austria, and Israel.
Developed by 3D Systems, Global Newswire reported that the innovative cranial implant solution, known as the "VSP® PEEK Cranial Implant," is designed to address skull defects resulting from traumatic injuries like fractures or gunshot wounds.
Cranioplasty procedures not only repair skull defects but also address conditions such as tumor removal and other medical issues affecting the skull. With the FDA's clearance, this customized 3D-printed solution can now be precisely tailored to fit each patient's unique skull structure.
Revolutionizing Cranial Surgery
This milestone approval signifies a significant advancement in medical technology and opens the door for the widespread adoption of 3D printing systems in the field of cranial surgery. The EXT 220 MED system incorporates medical-grade PEEK materials to provide personalized cranial reconstruction solutions for patients.
Leveraging 3D printing technology allows for the creation of custom implants using up to 65 percent less material than traditional methods. PEEK (polyetheretherketone), a high-performance polymer with properties resembling human bone, serves as the primary material for the implant. It is designed to offer superior mechanical strength and compatibility with the body.
The PEEK implant represents a groundbreaking advancement. It was the first of its kind to receive FDA clearance, affirming its safety and efficacy as a patient-specific medical device. PEEK's natural radiolucency ensures minimal interference with medical imaging, providing clearer evaluations of surgical sites and implant integrity.
The 3D printer and streamlined post-processing workflows enable precise manufacturing of implants tailored to patients' specific needs while managing costs effectively. This solution has already seen successful implementation in 40 patients undergoing cranioplasty surgeries across Switzerland, Austria, and Israel.
Dr. Gautam Gupta, Senior Vice President and General Manager of Medical Devices at 3D Systems, highlighted the significance of receiving FDA clearance for their VSP PEEK Cranial Implant solution, marking a significant milestone in their journey.
The EXT 220 MED printing system has facilitated the production of nearly 40 cranial implants, supporting successful cranioplasties throughout Europe. With FDA clearance, the VSP PEEK Cranial Implant can now be introduced to the U.S., establishing a new standard of excellence for these procedures.
The company is now exploring further applications for this technology, extending beyond cranial implants. These include 3D-printed spine interbody fusion implants, using carbon fiber-reinforced PEEK for plating in trauma and fixation procedures, and developing bioresorbable polymers for various large bone and craniomaxillofacial applications.
