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3D printed titanium maxillofacial implants receive clearance for the U.S. market.
Belgian 3D printing leader, Materialise has announced that it’s patient-specific implants, 3D printed in titanium for maxillofacial surgery, have been approved for use in the U.S..
The first of their kind to be given the green light for the U.S. market, the implants will be distributed by DePuy Synthes under the TRUMATCH CMF brand, further expanding Materialise’s longstanding collaboration with the Johnson & Johnson Medical Devices company.
The TRUMATCH titanium 3D printed implants are part of a personalised solution for orthognathic surgery, also known as corrective jaw surgery, and facial reconstruction. Having already reported positive results in European and Australian markets since its introduction in 2016, the system will help deliver better aesthetics and minimise surgery time for patients in the U.S. through virtual surgical planning to the 3D printed implants used in combination with 3D printed surgical guides.
The solution incorporates Materialise’s backbone of services including its software development, clinical engineering and 3D printing production facilities.
“As the first of our extensive selection of implants to receive clearance for the U.S. markets, the decision is a real milestone for our medical department,” said Brigitte de Vet, Vice President of Materialise Medical. “Thanks to our partnership with DePuy Synthes, our devices will be able to provide better healthcare for as many patients as possible.”
“For seven years now I’ve experienced the benefits of 3D printed implants firsthand – they simplify maxillofacial surgery and allow me to perform procedures more accurately, saving time in the OR and improving patient outcomes," Dr. Thomas Schouman, CMF surgeon at Groupe Hospitalier Pitié Salpêtrière, France, commented. "Moreover, they offer new treatment possibilities, allowing me to perform more complex surgeries or multiple procedures in a single intervention whereas without the implants several interventions would be necessary."
