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3D Systems’ additive manufacturing technologies enabling advances in the cranial implants market is anticipated to reach more than $2 billion by 2030.

Example of a cranial implant produced using VESTAKEEP® i4 3DF PEEK by Evonik on 3D Systems’ EXT 220 MED extrusion platform.

3D Systems announced a patient-specific 3D-printed cranial implant produced using its point-of-care technologies was successfully used in a cranioplasty at the University Hospital Basel (Switzerland). Under the leadership of Prof. Florian Thieringer, head of the Medical Additive Manufacturing Research Group (Swiss MAM) at the University Hospital Basel's Department of Biomedical Engineering (UNIBAS DBE), and the Department of Oral and Maxillofacial Surgery (OMFS), in collaboration with Prof. Raphael Guzman and the Department of Neurosurgery, the team employed 3D Systems’ technologies to produce the first cranial implant at the point of care that complies with the current Medical Devices Regulations (MDR).

3D Systems’ extrusion printing technology is unique as its architecture and design are easy to use to produce durable, biocompatible implants using Polyetheretherketone (PEEK) material. Additionally, the technology enables the production of patient-specific geometries at the hospital itself providing tremendous benefits to both surgeons and patients. The implant created by the team at University Hospital Basel was used to successfully replace a section of a disintegrating skull in a 46-year-old male who was experiencing complications from a stroke in 2019.

When the patient first entered Prof. Guzman’s care, he was experiencing visual disturbances, severe headaches, and dizziness, and his forehead was sinking due to a disintegrating skullcap. The University Hospital Basel team under the guidance of Dr. Neha Sharma, Ph.D. first took a computed tomography (CT) scan of the patient’s skull and imported that into software to create a model of the implant customized to his unique anatomy. The implant was then produced in the Hospital’s 3D printing lab using VESTAKEEP® i4 3DF PEEK by Evonik on 3D Systems’ EXT 220 MED extrusion platform. PEEK is a very desirable material for such applications due to its mechanical properties (i.e., lightweight, resistant to thermal and ionizing radiation, and similar to human bone). 3D Systems’ printing technology has been uniquely engineered to enable healthcare applications within sterile environments.

3D Systems’ point-of-care solution was also successfully used by a team at Salzburg University Hospital, Department of Oromaxillofacial Surgery, to produce a patient-specific cranial implant for a 55-year-old male, Mr. Rainer Trummer, who suffered from craniosynostosis (i.e., one of the cranial bones ossified too early during childhood, resulting in a deformation of the skull). These technologies were brought together by the hospital’s in-house clinicians to successfully address the patient’s needs, providing a customized solution that best positioned the team for success. The hospital used Oqton’s D2P® software to create 3D models from the patient's CT images and Oqton’s Geomagic Freeform® to complete the design of the patient-specific occipital prosthesis. The cranial implant was printed using VESTAKEEP® i4 3DF PEEK by Evonik on 3D Systems’ EXT 220 MED extrusion platform.

The solution has also been successfully deployed at the Department of Neurosurgery, University Hospital Salzburg, for patient-specific implants after decompressive craniectomy, which is regularly performed for aggressive brain swelling. According to Prof. Christoph Griessenauer, chairman of the department for neurosurgery in Salzburg, 40 decompressive craniectomies are performed in Salzburg annually. After the swelling subsides, the bone is replaced with a patient-specific cranioplasty implant. So far four cranioplasty surgeries have been performed within the last month, and multiple more are planned for the future.

It is anticipated that the use of 3D-printed cranial implants will accelerate based on the availability of advanced technologies. According to a report released 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.

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