Video of First Patient at the USB Receiving 3D-Printed Implant from In-House Production
This August, at the University Hospital Basel, a patient was implanted with an artificial skull cap that was manufactured in-house. The implant was fabricated for the patient at the USB using 3D printing. After years of research and development funded by the Werner Siemens Foundation, the USB has become the first hospital in Europe to successfully produce implants through the 3D printing process that meet international medical device standards. The video was produced by the amazing Digital Content Team of the University Hospital Basel.
At the end of August, the time had come: after several years of research and development work, a team of experts from the Department of Oral and Cranio-Maxillofacial Surgery (OMFS), in collaboration with the Department of Neurosurgery at the University Hospital Basel (UHB), was able to implant an artificial skull cap in a patient that had been produced in-house on a 3D printer. This is a milestone in modern medical technology - and makes the University Hospital Basel the first hospital in Europe to be able to produce in-house manufactured implants from 3D printers that comply with the current Medical Devices Regulations.
When the skull bone disintegrates
Thomas Wirth, now 46 years old, suffered a stroke in 2019. The brain hemorrhage meant that his skullcap had to be removed to equalize the pressure and then reinserted sometime later. However, this only went well for a few months: the calvaria, as the skullcap is known in medical terms, began to dissolve. At the same time, complaints such as visual disturbances, severe headaches, dizziness, and aesthetic concerns with skin sinking of the lateral forehead area appeared. Thomas Wirth came to the UHB as a patient of the neurosurgery department under the direction of Prof. Raphael Guzman. Soon, Prof. Guzman established a collaboration with the 3D implant printing project and the team led by surgeon Prof. Florian Thieringer: Here, various specialists had been working for some time to produce implants in the hospital's 3D printing lab that are precisely tailored to the patient, complying with legal requirements and can ultimately be inserted in the operating room.
From CT scan to finished high-performance plastic implant
"I've had several surgeries at University Hospital. I trust the team here and was looking forward to the operation in good spirits," said Thomas Wirth shortly before the operation. The insertion of the cranial implant represented the culmination of a highly complex internal workflow over several stations: For a precisely tailored implant, the experts at the UHB first take a scan using computed tomography (CT). The imaging data is then transferred to a 3D planning software, where an initial model is created. This is edited and adjusted on the computer to ensure that the implant exactly matches the patient's unique anatomical structure and fits perfectly during surgery. Finally, the implant is printed from the very well-tolerated high-performance plastic PEEK (Vestakeep i4 3DF from Evonik) using the 3D printer (Kumovis R1 from 3D Systems) near the operating room - layer by layer, fitting with millimeter precision and ready for life-changing use.
Important milestone: approval
Involved in the project are not only the various medical teams at the UHB but also biomedical engineers from the University of Basel (DBE) and the the Institute for Medical Engineering and Medical Informatics of the School of Life Sciences FHNW, as well as approval experts from POC APP AG in Basel. The topic of "approval" played a particularly important role throughout the innovation process: Compliance with the strict standards of the Medical Device Regulation (MDR) posed a particular challenge. This compliance with the MDR not only ensures patient safety and efficacy but also underscores the UHB's commitment to ethical and transparent research. "The close collaboration with international experts in the field of medical device regulation led to the UHB being the first hospital in Europe to successfully perform such an operation on a patient with an in-housemanufactured implant in compliance with the regulations," says Prof. Florian Thieringer. "So far, only a very few hospitals in the world that meet the local legal requirements can do this - the UHB is one of these world-leading centers in this field. And we are the first in Europe to have successfully qualified the entire process."
On the pulse of the medicine of the future
Only a few weeks have passed since the surgery - Thomas Wirth is motivated about the future. The operation has been successful and the UHB is following its "pilot patient" very closely during the recovery process. For both Thomas Wirth and the UHB, the operation represents a quantum leap: "I think it's great that new ground is being broken here and that the university hospital is creating advantages both technologically and financially," says Thomas Wirth. With that, he addresses the issue of costs: These can be reduced by in-house production as well as the material savings that did not take place in the past due to milling. Other advantages include the direct review of intermediate results along the entire production chain by the surgeons, quicker turn-around, and the high precision and durability of the implants. In the long term, the University Hospital would also like to use 3D printing to produce more complex implants, such as those for facial reconstruction or the spine. "The great result with our patient shows that the years of research have paid off," explains Prof. Florian Thieringer. "Today we have reached a milestone in the direction of personalized and efficient medicine - and Basel is establishing itself as a pioneer and innovation platform in the field of 3D printed medicine.“
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