3D Systems Announces FDA Clearance for World’s First 3D-Printed PEEK Cranial Implants - Seite 2

The VSP PEEK Cranial Implant is the first FDA-cleared, additively manufactured PEEK implant intended for cranioplasty procedures to restore defects in the skull. This implant-grade, high-performance polymer has a well-known clinical history in medical device applications due to its exceptional performance with mechanical properties closely mirroring human bone. In addition, PEEK has excellent biocompatibility, resistance to bodily fluids, and stability in a wide range of temperatures, making it an ideal choice for many medical device applications. Furthermore, its inherent radiolucency ensures minimal interference in medical imaging, facilitating a clearer evaluation of the surgical site and implant integrity.

“As a leader in medical device innovation, 3D Systems prides itself on pioneering advancements that benefit both surgeons and patients,” said Dr. Gautam Gupta, SVP & general manager, medical devices, 3D Systems. “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 fiber-reinforced PEEK for plating applications in trauma and fixation, and bioresorbable polymers for large bone and craniomaxillofacial applications.”

3D Systems has worked with surgeons for more than a decade to plan over 150,000 patient-specific cases and manufacture more than two million implants and instruments for 100+ CE-marked and FDA-cleared devices from its world-class, FDA-registered, ISO 13485-certified facilities in Littleton, Colorado and Leuven, Belgium.

This FDA clearance enables 3D Systems to significantly expand its PEEK product portfolio through the EXT 220 MED platform. With this milestone, the company is not just introducing a pioneering product; it is setting the stage for a comprehensive range of advanced PEEK-based solutions designed to meet the diverse needs of the medical field. 3D Systems' extensive experience in developing patient-specific, high-performance PEEK implants, combined with its robust database, places the company in an unparalleled position to accelerate the development process. This expertise is a valuable asset for all existing customers and partners, offering them an expedited pathway to bring their products to market. By leveraging 3D Systems' proven track record and the capabilities of the EXT 220 MED platform, the company is committed to supporting its partners in navigating the regulatory landscape more efficiently, ensuring faster access to innovative medical solutions that enhance patient care and outcomes.