3D Systems
The Food and Drug Administration (FDA) has provided 510(k) clearance for maxillofacial surgical guides produced with 3D Systems' LaserForm Ti and DuraForm ProX PA materials.
It comes after close collaboration between 3D Systems and medical supplier Stryker, after the two companies entered into a partnership in January 2018 to harness 3D printing technology to advance craniomaxillofacial procedures. The partnership centred on delivering ‘Virtual Surgical Planning’ (VSP) solutions using 3D Systems’ FDA-approved service encompassing medical imaging, surgical simulation and 3D printing.
With FDA 510(k) clearance of the LaserForm Ti and DuraForm ProX PA materials, 3D Systems says that surgeons will now be able to achieve ‘more innovative surgical guide designs’, improving performance and saving hours of time within the operating room. It is said to now be possible to design surgical guides with less overall material bulk, while also improving the strength and durability of parts.
Additionally, 3D Systems has mechanical validation testing data to show that guides are 20x stronger than traditional parts when made with Laserform Ti, while Nylon guides manufactured with ProX PA exhibit up to 88% higher toughness. Capabilities like this enable surgeons to design thinner guides which have a close, snap-like fit to the patient anatomy. The materials are also validated with a wide range of cleaning and steam sterilisation options, while also helping to facilitate designs customised to the cutting and drilling instrumentation used in surgery.
“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,” commented Menno Ellis, Executive Vice President, Healthcare Solutions at 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.”
