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Nov 26, 2018 | By Thomas
Materialise today announced that the Ultimaker S5 and Stratasys 3D printers has been certified by Materialise as a 3D printing solution to create orthopedic, maxillofacial and cardiovascular models for clinical use when used in combination with Mimics inPrint software.
In 2017, the FDA announced that software intended to create output files for 3D printing patient-specific anatomical models, which are used for diagnostic purposes, is considered a class II medical device and requires regulatory clearance. Materialise was the first company to provide a software that conforms to these regulations and can be used in U.S. hospitals in combination with a compatible 3D printer. After rigorous performance testing and analysis, Materialise and Ultimaker identified that the Ultimaker S5 printer, used in conjunction with PLA and PVA materials, can be safely used with the Materialise Mimics inPrint software for 3D printing models that are used for diagnostic purposes.
“More and more frequently, doctors look to 3D printing for pre-operative planning and the fabrication of physical models for patient management, treatment and surgeon-to-surgeon communications. As diagnostic usage of 3D printers continues to revolutionize patient care, safety and quality remain a top concern for hospitals,” said John Kawola, president of Ultimaker North America. “The Materialise certification of the 3D printing workflow when used with Mimics inPrint reduces the safety- and quality-control burden on doctors and hospitals with its clearance by the FDA.”
Materialise today also unveiled its partnership with Stratasys to expand the suite of 3D printers and materials as part of FDA-cleared Materialise Mimics inPrint software to produce patient-specific, life-like anatomical models for diagnostic purposes.
PolyJet multi-material and multi-color solutions validated now include the J750 and J735 3D Printers and the high-performance desktop Objet30 Prime 3D Printer. In March of 2018, Materialise Mimics inPrint was cleared by the FDA, becoming the only solution with 510(k) clearance as an end-to-end 3D printing solution, as well as a fully comprehensive 3D printing solution for anatomical modeling.
“Historically, pre-surgical planning relied on 2D imaging requiring physicians to mentally reconstruct the patient anatomy. But 3D printing evolves this approach by putting precise replicas of patient anatomy directly in physician hands. Our collaboration with Materialise is a huge step towards unlocking the potential of this technology for patient care,” says Eyal Miller, Head of Healthcare Business Unit, Stratasys. “Now the 3D printer that every hospital needs to power their medical modeling comes with additional options for an FDA-cleared software solution.”
According to company reports, of the top 20 U.S. hospitals as ranked by U.S. News & World Report, 16 have implemented a medical 3D printing strategy using Materialise Mimics technology.
“By validating Stratasys’ 3D printing technologies through our certification process, we’re giving doctors and hospitals improved access to high-quality anatomical models for personalized care to patients,” said Bryan Crutchfield, Vice President and General Manager of Materialise North America. “The addition of multi-color and multi-material printers to the list of validated printers is aimed to enable healthcare providers to implement a versatile offering that can support their most complex cases across a wide range of surgical specialties on a single printer.”
3D printed model of patient's left atrial appendage (LAA) created with Stratasys and Materialise technology (Image: Stratasys)
The Stratasys J735/J750 3D Printers are able to develop highly-complex models using multiple textures, while combining hard and soft materials to mimic human tissue. The unique combination of transparency with multiple color re-creation ensures practitioners can differentiate anatomy, view critical structures within an organ replica, and create realistic representations of any bone, tissue, and organ.
The Stratasys’ Objet30 Prime 3D Printer is a cost-effective, desktop platform providing an entry point to hospitals seeking a point-of-care printing solution. The versatile offering supports a range of anatomical models and applications, including orthopedic, cardiac, neurosurgery and other use-cases for visualization, surgical planning, training and education.
Posted in 3D Printer Company
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