3D Systems Announces FDA Clearance forWorld’s First 3D-Printed PEEK Cranial Implants

Article source: 3D Systems press release

The VSP PEEK Cranial Implant is the first FDA-cleared, additively manufactured PEEK implant intended for cranioplasty procedures to restore defects in the skull.

• FDA clearance enables wide-spread adoption of 3D Systems self-contained, cleanroom environment-based printing system, the EXT 220 MED, with medicalgrade PEEK materials to deliver patient-specific cranial reconstruction solutions

• 3D-printed PEEK implants using the EXT 220 MED successfully demonstrated in nearly 40 cranioplasties across Europe in recent months

• Market for cranial reconstruction anticipated to exceed $2 billion by 2030

• FDA clearance establishes strong foundation for expanded application of these unique, cost-effective technologies to additional orthopedic surgical indications

ROCK HILL, South Carolina, April 15, 2024 – Today, 3D Systems (NYSE:DDD) announced the 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 complete 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 pre-defined production process. By utilizing additive manufacturing solutions, this technology can produce patient-specific cranial implants with up to 85% less material than similar implants produced by traditional machining, which can lead to significant cost savings for an expensive raw material like implantable PEEK. Furthermore, the cleanroom-based architecture of the printer combined with simplified post-processing workflows makes it an ideal technology for producing patient-specific medical devices at the hospital site with faster turnaround while keeping the overall cost under control. 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.

Professor Christoph Griessenauer (l.) and senior physician Johannes Pöppe from the University Clinic for Neurosurgery at the CDK University Hospital Campus

“3D-printed PEEK cranial plates are an innovative solution that can improve patient care and expand the possibilities for precise, individualized neurosurgery,” said Dr. Johannes Pöppe, senior attending surgeon, department of neurosurgery, University Hospital Salzburg. “The solution is revolutionizing the field. The combination of 3D Systems’ printing technology that is uniquely engineered for sterile environments along with the mechanical properties of PEEK are helping surgeons push boundaries. Within our hospital, we have already completed several successful surgeries using these technologies. I believe the potential for customized PEEK cranial plates is significant to integrate 3D printing into routine clinical practice.”

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, highperformance 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.

This model was created before surgery to check the fit of the implant. © SALK/Fürweger

“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 patientspecific cases and manufacture more than two million implants and instruments for 100+ CEmarked and FDA-cleared devices from its world-class, FDA-registered, ISO 13485-certified facilities in Littleton, Colorado and Leuven, Belgium.

The EXT 220 MED with its filament-based extrusion technology enables printing of medical implants and instruments using high performance polymers, including PEEK, resomers and Radel® PPSU. It is the only platform with an integrated clean room and temperature controls to enable high-quality device production.

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.

This model was used in a 59-minute operation on September 12th. You can see the plates through which the implant was screwed to the skull and the holes through which the meninges were sewn to the implant. © SALK/Fürweger

It is anticipated that the use of 3D-printed cranial implants will accelerate 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. The continued innovation in materials and manufacturing methodologies such as 3D printing are expected to enable new solutions to catalyze growth in this market.

Certain statements in this press release are forward-looking, based on the management's expectations but subject to risks and uncertainties that may cause actual results to differ. 3D Systems, having introduced 3D printing technology 35 years ago, is now a leading partner in additive manufacturing, providing innovative solutions to industries like healthcare, aerospace, and automotive. Our application engineers collaborate with customers to create unprecedented products and business models. For more information, visit 3D systems.

Press release source: 3D Systems

Image source: © SALK/Fürweger