BioArchitects announced today the 510(k) clearance by the U.S. Food and Drug Administration – FDA, for the company’s 3D printed patient specific titanium cranial/craniofacial plate implant. Designed for the repair of defects in the non-loadbearing bones of the head and face, each custom designed plate is permanently attached to the skull and/or face with self-tapping titanium screws.
This first of its kind U.S. device makes use of cutting-edge 3D printing technology from Arcam AB, also known as additive manufacturing, taking advantage of the properties of light weight and high tensile strength of the biocompatible titanium alloy made from Arcam’s Electron Beam Melting (EBM) technology.
“We are extremely proud to contribute to what we consider another major advance in the trend toward personalized medicine. We believe that this is yet another step toward what will ultimately become the new standard of care”, according to Mark Ulrich, CEO of BioArchitects USA.
Devices of this kind are typically used in the repair of bony defects resulting from trauma, disease, or congenital abnormalities. As each device is specific to a single individual, its construction begins with the taking of a CT scan or MRI of the affected area. The scan or image is then imported into a highly sophisticated computer design program, which is used to create a template of the repair that becomes the model from which the 3D printer produces the titanium plate, to the specific dimensions of the design. The resulting plate is the exact fit for the defect, not unlike the positioning of a jigsaw puzzle piece. Getting from CT scan or MRI, the finished plate is the end-product of collaboration between the surgeon and the biomedical engineer responsible for the design.
“BioArchitects is a prime example of how innovative organizations are using EBM technology to advance biomedical surgeries that truly effect people’s lives,” said Magnus Rene CEO of the Arcam Group. “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.”
BioArchitects is a design and manufacturing enterprise, dedicated to produce patient specific solutions, including permanent implants, surgical planning models and surgical guides – all produced by means of 3D printing. The company, with operations in both the U.S. and Brazil, counts among its clients some of the major healthcare institutions in both countries. www.bioarchitects.com
Arcam Group provides cost-efficient Additive Manufacturing solutions for production of metal components. Arcam’s Electron Beam Melting (EBM®) technology offers design freedom combined with excellent material properties and high productivity. Arcam is, through its solution orientation and comprehensive product offering, an innovative partner for advanced manufacturing, primarily for the aerospace and medical industries. Arcam offers EBM systems through Arcam AB in Sweden, powder metals through AP&C in Canada and implant contract manufacturing through DiSanto in the U.S.The company is listed on Nasdaq Stockholm and the Head Office is located in Mölndal, Sweden. www.arcam.com