Health Canada authorizes the use of a 3D printed mandibular implant “


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The medical 3D printing industry marked an exciting milestone in Canada this week: Health Canada (a ministry responsible for national health policies) approved a 3D printed medical implant manufactured by LARA 3D in Quebec. The 3D printed device, a patient-specific mandibular plate, is the first manufactured by a Canadian manufacturer to obtain implantation authorization.

LARA 3D (the 3D anatomical reconstruction laboratory) is based at Investissement Québec (CRIQ), a provincial research institute which now houses more than 800 innovative projects. The 3D printed medical implant was developed and manufactured in the CRIQ facilities in Quebec. The implant, officially called the Specifit 3D Mandibular Plate, is a customizable 3D printed device used for mandibular reconstruction in patients diagnosed with oral cancer.

“We are extremely proud to announce Health Canada’s approval of the 3D Specifit Mandibular Plate. Not only will this improve the quality of life for patients; but thanks to optimized, guided and personalized surgery, it will also allow the development of a center of expertise in 3D medical equipment at the CHU de Québec – Université Laval research center ”, declared Dr. Gaston Bernier DMD, medical chief , dentistry and oncology. at the CHU de Québec-Université Laval. “We are convinced that the approval of this technology marks only the beginning of innovation, research and development in 3D medical printing at LARA 3D. “

The LARA 3D laboratory was launched a year ago and received ISO 13485 certification in April 2021. This certification proves the laboratory’s ability to produce new medical devices that meet demanding standards and quality specifications for healthcare applications. Health Canada officially approved the 3D printed medical implant in September 2021; Now, surgeons and healthcare professionals will begin to use the specific mandibular plate, as well as the surgical cutting and drilling guides, to treat patients.

The implantable device is made from biocompatible metals and is printed by laser fusion and powder bed electron beam. Because the implant can be tailored in size and dimensions to suit the specific anatomy of the patient, it reduces operating times and patient recovery times.

From a broader perspective, the medical device (and its approval by Health Canada) demonstrates Quebec’s proactive approach to health technologies. LARA 3D’s installations have not only enabled the development and certification of this implant, they also allow many other innovative projects carried out by public-private cooperation. In the case of this implant, CRIQ collaborated with researchers from the CHU de Québec-Université Laval as well as with Alkom Digital, a manufacturer of orthopedic screws in the private sector, and AP&C, a Quebec manufacturer of metal powder belonging to GE.