Brazil and U.S. based company BioArchitects recently announced the approval of their customized 3D printed titanium cranial/craniofacial plate implants by the U.S. Food and Drug Administration (FDA).
The patient specific cranial/craniofacial titanium implants, which are the first of their kind in the United States, are made using Swedish additive manufacturing company Arcam AB’s Electron Beam Melting (EBM) technology. The technology allows for the implants to be custom designed for each patient using a a strong, high tensile, and lightweight titanium alloy.
“We are extremely proud to contribute to what we consider another major advance in the trend towards personalized medicine,” says Mark Ulrich, CEO of BioArchitects USA. “We believe that this is yet another step toward what will ultimately become the new standard of care.”
The FDA approved implants are meant specifically for non-loadbearing bones in the face and skull, and will be used mostly to treat and repair bone defects caused by trauma, disease, and congenital abnormalities. The 3D printed titanium plates will be permanently connected to the skull or face that is afflicted with self-tapping titanium screws.
Like with most 3D printed custom implants, the process of creating BioArchitects’ recently approved plates begins with a CT or MRI scan of the patient’s affected area. From there, the detailed scan of the bone is turned into a 3D model which is then turned into the model for the 3D printed implant. This technology allows for the implant plates to be perfectly sized and matched to the patient they will be transplanted into. The process combines the skills of surgeons and biomedical engineers who create the implants.
To receive the FDA’s 510(k) clearance, BioArchitects had to perform several tests on their 3D printed custom implants to prove their quality and strength. Reportedly, after the testing, the company found that their attachment tabs, the weakest part of the implant, were in fact three to four times stronger than commercially made attachment brackets.
Arcam AB, the company responsible for additively manufacturing the titanium cranial/craniofacial implants, has provided BioArchitects with their EBM technology, which uses a powerful electron beam to melt layers of metal powder into the exact dimensions of the 3D model sent to it. The Swedish 3D printing company recently opened an office in the United States, expanding their medical and aerospace 3D printing solutions.
Magnus Rene, CEO of the Arcam Group says of the collaboration, “BioArchitects is a prime example of how innovative organizations are using EBM technology to advance biomedical surgeries that truly effect people’s lives. Arcam has been a strategic supplier to the orthopedic market for over a decade and tens of thousands of implants are made yearly from our EBM systems. It is clear that both BioArchitects and Arcam are advancing patient care with new technologies that will make a significant difference in the world of medicine for years to come.”
The FDA approval is significant for BioArchitects, a company dedicated to creating and developing customized and patient specific medical solutions not only in the realm of implants but also for surgical planning models and guides.