Medical & Dental

FDA clears Materialise Mimics Enlight for catheter-based cardiovascular procedures

Belgian 3D printing software company Materialise has received FDA approval for Mimics Enlight, a 3D modeling software for planning cardiovascular surgery.

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.”

“With the FDA clearance of Mimics Enlight, we are expanding the 3D toolkit for cardiologists working to treat patients with complex cardiovascular issues, starting with mitral valve replacement.”


Mitral valve disease

Mimics Enlight was developed in collaboration with Henry 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 the Henry Ford Center for Structural Heart Disease, played an instrumental role in the production of Mimics Enlight. The software is specifically used for planning complex transcatheter mitral valve replacement (TMVR) procedure.

Mitral valve is located between the left atrium and left ventricle of the heart. Among several types of mitral valve diseases, it is reported that mitral regurgitation is the most common in developed countries, approximately 10% of the over 75 population suffers from the disease.  

Although mitral valve repair or replacement is the best treatment for the disease, patients are not referred for surgery as often by their doctors. 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 Abbott Vascular and Carillon by Cardiac Dimensions in Washington. 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. 

A diagram of mitral valve regurgitation disease. Image via Temple Health.
A diagram of mitral valve regurgitation disease. Image via Temple Health.

Materialise and surgical planning

Since the revised guidelines of the FDA, software is considered a medical device. Therefore, 3D modeling software used for planning and performing surgery require FDA approval. As such, Materialise’s Mimics Innovation Suite was the first 3D printing software to receive FDA approval. Since then Materialise has also validated 3D printers like the Ultimaker S5 and Stratasys J750 and J735 for use with Mimics Innovation Suite.

On the FDA approval of Mimics Enlight, Brigitte de Vet-Veithen, vice president of Materialise Medical, said, “Materialise has a wealth of medical technology and experience built throughout two decades of development and implementation of the Mimics Innovation Suite.” de Vet-Veithen added, “That expertise in delivering patient-specific solutions serves as the foundation for Mimics Enlight Mitral’s ability to consistently view and measure each patient’s complex mitral valve anatomy.”

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.”

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Featured image shows planning cardiac surgery with Mimics Enlight. Image via Materialise.