By Eric Hal Schwartz
Hospitals might soon end up with 3D printers next to their X-ray machines now that the FDA has approved a 3D-printed skull bone replacement implant. The implant, technically called the OsteoFab Patient-Specific Facial Device (OPSFD), is basically a specialized hard plastic that is similar to bone, and printed in to finely mimic the facial bone that is missing in shape and function. If your cheek bone were to be shattered beyond normal repair, this implant could help ensure you could soon look and function about as well as you did before. Oxford Performance Materials, which created the implant, was also the first to get FDA approval a similar implant for the cranium, the part of the skull that is not the face.
“There has been a substantial unmet need in personalized medicine for truly individualized – yet economical – solutions for facial reconstruction, and the FDA’s clearance of OPM’s latest orthopedic implant marks a new era in the standard of care for facial reconstruction,” said Scott DeFelice, OPM’s CEO in a statement. “Until now, a technology did not exist that could treat the highly complex anatomy of these demanding cases. With the clearance of our 3D printed facial device, we now have the ability to treat these extremely complex cases in a highly effective and economical way, printing patient-specific maxillofacial implants from individualized MRI or CT digital image files from the surgeon.”
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