3D Systems Announces FDA Clearance for World’s First 3D-Printed PEEK Cranial Implants
- FDA clearance for 3D-printed VSP PEEK Cranial Implant
- Up to 85% less material usage compared to traditional machining
- Successful use in nearly 40 cranioplasties in Europe
- Market for cranial reconstruction expected to exceed $2 billion by 2030
- PEEK material offers exceptional performance and biocompatibility
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With the FDA's 510(k) clearance of 3D Systems' VSP PEEK Cranial Implant, we are observing a significant enhancement in the medical devices sector's efficiency and customization. The application of PEEK material in cranial implants is not new; however, this development streamlines the conventional manufacturing process. PEEK's similarity to human bone mechanics and biocompatibility is well-documented and its suitability for patient-specific implants has been established.
The reduction in material use by up to 85% can lead to considerable cost savings, an essential consideration for hospitals and healthcare systems. Moreover, the on-site production capabilities of the EXT 220 MED 3D printer could reduce logistics costs and wait times for patients, further enhancing the value proposition of this technology. There is potential for market expansion as the adoption of these implants grows due to their cost-effectiveness and customization benefits.
The clearance for 3D-printed cranial implants underscores a trend toward personalized medicine, which carries broad economic implications for the healthcare sector. As the market for cranial reconstruction is predicted to nearly double by 2030, the entry of an FDA-cleared, cost-effective and efficient manufacturing process represents a strategic move in an expanding market. The technology's scalability is a boon, with potential cost savings from reduced material use and production at point-of-care likely translating to lower overall healthcare expenditures.
Adoption of this technology may spur downstream economic effects, including changes in surgical planning, shorter hospital stays and potentially improved patient outcomes. Insurers and payers will take interest in the economic benefits of these outcomes. The positive reception of initial surgeries in European hospitals provides a glimpse into the technology's acceptance and the potential for widespread clinical adoption in the U.S. market.
3D Systems' FDA clearance is not only a technical milestone but also a pivotal market development. The company's entrenched position, with over a decade of experience and two million implants and instruments produced, lends credibility and assurance to potential adopters. The move can attract attention from investors looking for innovative growth opportunities within the medical devices industry.
Commercialization of the VSP PEEK Cranial Implant is likely to stimulate competitive response and catalyze further innovation within the sector. As 3D Systems broadens its PEEK portfolio, market dynamics may shift, with an emphasis on rapid product development cycles and regulatory agility. The convergence of advanced manufacturing and healthcare is creating new investment frontiers and 3D Systems is positioning itself at the forefront of this transformation.
- FDA clearance 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
- 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, S.C., April 15, 2024 (GLOBE NEWSWIRE) -- 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
“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, 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.
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
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About 3D Systems
More than 35 years ago, 3D Systems brought the innovation of 3D printing to the manufacturing industry. Today, as the leading additive manufacturing solutions partner, we bring innovation, performance, and reliability to every interaction - empowering our customers to create products and business models never before possible. Thanks to our unique offering of hardware, software, materials, and services, each application-specific solution is powered by the expertise of our application engineers who collaborate with customers to transform how they deliver their products and services. 3D Systems’ solutions address a variety of advanced applications in healthcare and industrial markets such as medical and dental, aerospace & defense, automotive, and durable goods. More information on the company is available at www.3dsystems.com.
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