3D系统 Attains FDA Clearance for 用料 for 3D Printed Surgical Guides

The additions to 3D系统’ VSP products offer the maxillofacial surgeon a portfolio of options for precise patient treatments.

The additions to 3D系统’ VSP products offer the maxillofacial surgeon a portfolio of options for precise patient treatments.

3D系统’ surgical guides produced 使用 special materials as part of its VSP(虚拟手术计划) System 提供设计选项的灵活性, and are capable of having lower profile designs, while also possessing improved strength 和 rigidity. Image courtesy of 3D系统.


3D系统 已经宣布 美国食品药品监督管理局(FDA)已为3D打印的颌面外科手术指南提供了510(k)许可 using its LaserForm Ti 和 DuraForm ProX PA materials. 新的间隙允许进行更多的手术指南设计,从而提高性能和 is the latest delivery 上 3D系统’方法可满足执行颌面和重建手术的外科医生的需求。

3D系统’ surgical guides produced 使用 these materials as part of its VSP(虚拟手术计划) System 提供设计选项的灵活性, and are capable of having lower profile designs, while also possessing improved strength 和 rigidity. 

3D系统’VSP技术结合了医学成像,手术模拟方面的专业知识,获得了FDA市场许可,成为基于服务的个性化手术方法 and 3D printing. The surgeon initiates the process, bringing their clinical knowledge 和 desired surgical plan to an 上line web meeting with a 3D系统 biomedical 恩 gineer to simulate 和 plan the surgical procedure. The outcome is a digital plan that is transferred to the operating room via 3D printed patient-specific models, guides, 和 templates. 3D系统 has provided VSP solutions or anatomical services in more than 120,000 patient cases.  

“通过与外科医生和Stryker的密切合作’s CMF division, we’发现了许多机会,可以利用我们材料组合中的其他功能来完善VSP指南设计,” says Menno Ellis, executive vice president, healthcare solutions, 3D系统. “我们专业的生物医学工程师现在能够设计针对外科医生的手术指南’具有增强特性的需求,可以帮助提高准确性并以以前不可能的方式简化程序。”

改良的手术指南设计 

现在可以设计总体材料体积较小的外科手术导向器,同时提高强度和耐用性。机械测试表明 LaserForm Ti生产的钛切割和标记指南 are stronger than traditional guides, according to 3D系统. 随着强度的提高,钛腓骨切割导向器可以比传统导向器更薄, 该公司补充说,这有利于改善手术部位。 

同样,DuraForm ProX PA中生产的尼龙标记指南 表现出更高的韧性 rendering them better able to withstand forces applied during surgery, according to 3D系统. This 恩 ables the creation of thinner guides than previously possible 和 facilitates a close, snap-like, fit-to-patient anatomy.

治疗方案的灵活性

With the new clearance, 3D系统 offers a portfolio of material 和 guide design options that provides surgeons with flexibility. The new materials 所有ow for customizable designs, tailored to the cutting 和 drilling instrumentation to be used in surgery, to assist surgeons with accurately performing cutting 和 drilling operations, 3D系统 says.

Additionally, the guides created 使用 LaserForm Ti和DuraForm ProX PA have been validated with a wider range of cleaning 和 steam sterilization options. Users now have more flexibility in 使用 manual or automated cleaning methods, 和 the devices can be steam sterilized 使用 a wrap or pouch under a wider range of accepted sterilization cycles. 

Sources: Press materials received from the company 和 additional information gleaned from the company’s website.

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