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3D Printed Titanium Cranial/Craniofacial Implant from BioArchitects Approved by FDA

by • February 3, 2016 • No Comments

logo_batopoffA facial injury or deformity is one of the most traumatizing things that can take place to a man. There’s the inevitable social stigma, the discomfort with being in public, but a severe injury to the face or head can interfere with worthwhile functions – breathing, eating, etc. For a long time, there was just so much that may be done to repair injure to the face; risk may be minimized, but folks were frequently left with worthwhile scarring for life. That’s changed quite rapidly in new years as 3D printing has created it possible to reconstruct bones, muscles and actually skin, and the innovation hasn’t stopped advancing.

biocranialBioArchitects, that operates out of both the United States and Brazil, specializes in reconstructive implants. Whilst most medical companies are startning to incorporate 3D printing into their surgical devices and procedures, BioArchitects has been via it exclusively for their surgical models and implants. Their patient-specific implants, customized to replace complex tissue, are 3D printed with a biocompatible titanium alloy that causes no adverse reaction and improves patient outcomes.

Currently, BioArchitects revealed that their 3D printed, patient-specific titanium cranial/craniofacial implant has been granted 510(k) clearance by the FDA. This is big news for the reason it allows for the company to start marketing the device, the initially of its kind in the United States.

“We are amazingly proud to offer to what we consider another worthwhile advance in the trend in the direction of manalized medicine,” said Mark Ulrich, CEO of BioArchitects USA. “We believe that this is yet another step in the direction of what can ultimately become the new standard of care.”

cranio2-460x460The titanium plate was created to repair defects and injure to the non-loadbearing bones in the head and face. A CT or MRI scan is taken of the patient’s head, and the images are utilized to print a titanium plate that exactly fits the injured area – “not unlike the positioning of a jigsaw puzzle,” according to BioArchitects. The implant is attached to the surrounding bone via self-tapping titanium screws.

The devices are printed via electron beam melting (EBM) innovation, patented by metal additive making corporation Arcam AB. The system, that – as its name suggests – uses electron beams to melt and fuse metal powders at high temperature and high speed, resulting in metal products that are lightweight, sturdy and amazingly exact – properties that have created the innovation quite talked about in the manufacture of orthopedic devices and implants.

arcam

“BioArchitects is a prime example of how new organizations are via EBM innovation to advance biomedical surgeries that truly effect folks’s lives,” said Magnus René, 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 created annual of our EBM systems. It is clear that both BioArchitects and Arcam are advancing patient care with new technologies that can manufacture a worthwhile difference in the world of medicine for years to come.”

Discuss these new medical devices in the 3D Printed Titanium Implants forum over at 3DPB.com.