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Oxford Performance Materials, Inc. has just announced the FDA approval of its revolutionary 3D printed OsteoFab Patient Specific Facial Device.
The implant is the first and only 3D polymeric implant to be cleared by the FDA for use with facial reconstruction.
Designed to be biocompatible with a similar mechanical structure to bones, the device will be printed by OPM Biomedical using the company’s OsteoFab process, a combination of laser sintering technology and OXPEKK powder.
“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 and Chairman of Oxford Performance Materials. “This is a classic example of a paradigm shift in which technology advances to meet both the patient’s needs and the cost realities of the overall healthcare system.
The development could have a substantial positive impact on facial implant surgery with accurate devices printed specifically for the individual and reduced operating times which will result in shorter hospital stays.
“An exciting aspect of our technology is that additional complexity does not increase manufacturing cost, and having both cranial and facial devices cleared now enables us to answer ever more complex cases where upper facial structures can be incorporated with cranial implants as a single device,” added Severine Zygmont, President of OPM Biomedical.
Last year, OPM was granted FDA approval for its OsteoFab Patient Specific Cranial Device for its cranial prosthetics line, making OPM the only company to receive FDA clearance to manufacture 3D printed patient specific implants.