Belgian 3D printing software companyMaterialise已收到FDA批准Mimics Enlight, a 3D modeling software for planning cardiovascular surgery.
布莱恩·克鲁奇菲尔德（Bryan Crutchfield）, vice president and general manager of Materialise North America, said, “We believe in the power of our mission to create a better and healthier world […] We work very closely with teams at our partner hospitals and medical device companies to identify areas where 3D planning and printing can improve their ability to plan procedures.”
“随着FDA的模拟启蒙清除率，我们正在扩展3D工具包，用于心脏病专家，从事二尖瓣替代术开始，以治疗患有复杂心血管问题的患者。”
二尖瓣疾病
Mimics Enlight was developed in collaboration withHenry Ford Health System, a Detroit-based healthcare organization established by the American industrialist Henry Ford. Dr. Dee Dee Wang, Director of Structural Heart Imaging at theHenry Ford Center for Structural Heart Disease, played an instrumental role in the production of Mimics Enlight.该软件专门用于计划复杂的经导管二尖瓣更换（TMVR）程序。
Mitral valve is located between the left atrium and left ventricle of the heart. Among several types of mitral valve diseases, i据报道mitral regurgitation is the most common in developed countries，大约75个人口中约有10％患有该疾病。
尽管二尖瓣修复或置换是该疾病的最佳治疗方法，但患者不会经常被医生转诊。This is due to the perceived risk of surgery.
Over the years, companies have manufactured devices for less invasive transcatheter mitral valve repair treatments. Such devices include MitraClip by California-based雅培血管and Carillon by心脏尺寸在华盛顿。But even though the devices are available for implantation, performing the surgery remains a formidable challenge.
Mimics Enlight was specifically designed to aid the surgical planning of TMVR. The software can design patient-specific 3D models which can be studied for implanting the surgical devices accurately. For effective planning of cardiac surgery, Mimics Enlight also generates reports and workflows.
实体和手术计划
Since therevised guidelines of the FDA，软件被认为是医疗设备。因此，用于计划和执行手术的3D建模软件需要FDA批准。因此，物质化的模拟创新套件是第一个3D打印软件获得FDA批准。从那时起，物质化还验证了3D打印机Ultimaker S5andStratasys J750 and J735for use with Mimics Innovation Suite.
在FDA批准模仿启蒙的批准下，Mitalize Medical Medical副总裁Brigitte de Vet-Veithen说：“物质化拥有丰富的医疗技术和经验，在模拟创新套件的开发和实施二十年中。”De Vet-Veithen补充说：“提供特定于患者的解决方案方面的专业知识是模仿启蒙二尖瓣能够始终如一地查看和测量每个患者复杂二尖瓣解剖结构的能力的基础。”
De Vet-Veithen commented on the effectiveness of Mimics Enlight, “Using a 3D model created in Mimics Enlight Mitral improves physicians’ ability to understand and plan procedures before entering the cath lab and gives them the reliable measurements critical to successful implantation of TMVR devices in highly diseased hearts.”
要了解有关3D软件如何改变医疗行业的更多信息，请订阅我们3D打印新闻通讯并加入我们Facebookand推特。
Visit our3D打印作业开始制造业的新职业。
Featured image shows planning cardiac surgery with Mimics Enlight. Image via Materialise.
