The FDA cleared Materialise’s 3D-printed titanium implants for maxillofacial surgery. Johnson & Johnson’s DePuy Synthes unit will distribute the implants in the U.S., starting in mid-September.
The Trumatch implants are the first 3D-printed titanium maxillofacial implants to score clearance in the U.S. They are designed for facial reconstruction and orthognathic surgery, or corrective jaw surgery. The implants are part of a total solution, Trumatch Orthognathics, which includes surgical planning and 3D-printed surgical guides.
The personalized implants are designed based on a CT scan of the patient’s skull and the outcome of computer-aided surgical planning, DePuy said in a statement.
The U.S. launch of the Trumatch maxillofacial implants follows the Australian and European launches in 2016, DePuy said.
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“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,” said Thomas Schouman, a craniomaxillofacial surgeon at Groupe Hospitalier Pitié Salpêtrière, France, in a statement. “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.”
Materialise and DePuy first teamed up on craniofacial surgery in 2010 and last year, partnered to provide surgeons with 3D-printed, personalized surgical guides for maxillofacial surgery.