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11/02/2024 09:41:57 am

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3D-Printed Face Implant is FDA Approved

Oxford 3D printing

(Photo : Oxford Performance Materials) Oxford 3D printed section of damaged skull

The U.S. Food and Drug Administration has approved Oxford's OsetoFab Patient-Specific Facial Device, a customizable implant for facial reconstruction for patients with disfiguring diseases and trauma.

In 2013, Oxford Performance Materials made headlines when the company manufactured a 3D-printed prosthetic to substitute 75 percent of a patient's skull. The operation introduced 3D printing into the land of the conventional medical treatments and laid the groundwork to work on other bones in the body

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The biocompatible implants, which are made from polyetherketoneketone, mechanically behaves like real bone.

The breakthrough in the application of the technology is the capability to manufacture skull fragments to match a specific patient's individual anatomy in a method that decreases the total cost of the complicated procedures needed to surgically rebuild a face after disfiguration.

The patient can undergo facial reconstruction surgery sooner rather than later as the implants can be created very rapidly.

"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," said Scott DeFelice, chief executive officer of Oxford Performance Materials.

DeFelice described it as a paradigm shift where advances in technology meet both the cost realities of the healthcare system and the individual patient's needs.

The FDA also approved Oxford's 3D-printed cranial implants that could be potentially integrate with implants for the face into one unit for treating serious cases. Although the manufacturer said the facial implants are currently available to hospitals and doctors, the prostheses have not yet been used in the United States.

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