CHU de Québec-Université Laval and Investissement Québec – CRIQ have announced Health Canada’s approval of the first 3D printed medical implant by the 3D anatomical reconstruction laboratory (LARA 3D) at Investissement Québec – CRIQ’s facilities in Quebec City.
Remember, last year, LARA 3D, a Quebec-based infrastructure has been launched for the manufacture of patient-specific implantable prostheses. In the meantime, the production medical center has been ISO 13485 certified, and has received approval to treat patients and produce the 3D Specifit mandibular plate along with surgical cutting and drilling guides.
This 3D printed implantable medical device marks a milestone for Canada as it is the first time a Canadian organization has been granted authorization for such a production.
The 3D Specifitmandibular plate, patient-specific device, will be used for mandibular reconstruction of patients with oral cancer.
From a medical perspective, surgeons are no longer limited to adapting a patient’s physiology to prostheses with predetermined dimensions. Instead, patient-specific implants made before surgery, designed from the patient’s internal imaging, follow the unique contours of the bone to be repaired. LARA 3D uses biocompatible metals for 3D printing by laser and electron beam powder bed fusion.
The use of patient-specific metal prostheses that are printed instead of traditionally manufactured will improve the quality of healthcare in Quebec by reducing patient’s surgery and recovery times, hence improving their quality of life.
The approval of the first 3D Specifit product signals the recognition of Quebec’s expertise in medical 3D printing. Other innovations are in the pipeline in partnership with the private sector, which will benefit from the knowledge and facilities available at LARA 3D.
Nearly $8 million in investments were required to construct the facilities and pay for the equipment and human resources needed for R&D and the certification process. The Government of Quebec provided $3,477,873 in funds through Programme de soutien à la recherche, volet 2 – Soutien au financement d’infrastructures de recherche, a research support program that allocated funds for research infrastructure.
This project illustrates the innovation possibilities that arise when professionals from different worlds —namely a university hospital, CHU de Québec-Université Laval, and an applied industrial research center, Investissement Québec – CRIQ — join forces. From the private sector, the orthopedic screw manufacturer Alkom Digital and the producer of metal powders for 3D printing AP&C were also involved. Axelys (formerly SOVAR), an organization supporting researchers and entrepreneurs for the development and transfer of innovation from public research, participated in the financing of about $225,000 through Programme de soutien aux organismes de recherche et d’innovation (PSO), volet 2d, dedicated to technological maturation.
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