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3D Systems Gains FDA Clearance for Patient-Matched Surgical Guidance

        3D Systems Patient-Matched Surgical Guides

  3D-printed maxillofacial surgical guides

3D Systems was granted FDA 510(k) clearance for 3D-printed maxillofacial surgical guides made with LaserForm® Ti and DuraForm® ProX PA materials. 3D Systems’ surgical guides produced using these materials as part of its VSP® System offer flexibility in design options, and can produce lower profile designs to enhance visibility and access in the surgical site, while also possessing improved strength and rigidity. 

3D Systems’ VSP technology received FDA market clearance as a service-based approach to personalized surgery, combining medical imaging, surgical simulation and 3D printing. The surgeon brings a desired surgical plan to an online web meeting with a 3D Systems biomedical engineer to simulate and plan the procedure. The outcome is a digital plan that is transferred to the O.R. via 3D-printed patient-specific models, guides and templates. 3D Systems has provided VSP solutions or anatomical services in more than 120,000 patient cases.

3D System’s new material options allow for surgical guide designs that improve performance in surgery. Surgical guides can be created with less overall material bulk while improving strength and durability. Mechanical testing shows that Titanium cutting and marking guides produced in LaserForm Ti are 20x stronger than traditional guides. With the improvement in strength, Titanium fibula cutting guides can be 70% thinner than traditional guides.

In 2018, 3D Systems announced an exclusive partnership with Stryker’s CMF division to deliver innovative solutions to the maxillofacial surgeon. The new clearance and enhancements to 3D Systems’ VSP System are the latest delivery on the companies’ shared objectives. The new guide designs and materials are compatible with Facial iD®, Stryker’s market-leading portfolio of patient-matched plating solutions. The combined surgical planning, improved patient-matched guides, and patient-specific implant system offers the maxillofacial surgeon a complete end-to-end solution for patient-matched treatment. Surgeons can request more information through Stryker's CMF representatives.

“Through close collaboration with surgeons and Stryker’s CMF division, we’ve uncovered opportunities to refine VSP guide designs that leverage additional capabilities in our materials portfolio,” said Menno Ellis, Executive Vice President, Healthcare Solutions, 3D Systems. “Our expert biomedical engineers are now able to design surgical guides tailored to the surgeon’s needs with enhanced properties that can help improve accuracy and facilitate procedures in ways not previously possible. Our powerful VSP System continues to transform surgery – enabling better patient outcomes.”