FDA Clears Cardiovascular Planning Software Created by Plymouth Township’s Materialise, Detroit’s Henry Ford Health System

Materialise, a global 3-D printing software and solutions company based in Belgium with locations in Plymouth Township and Ann Arbor, has received FDA clearance for its Mimics Enlight cardiovascular planning software suite, which was created in collaboration with Detroit’s Henry Ford Health System.
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Materialise Mimics Enlight
Materialise has received FDA clearance for its Mimics Enlight cardiovascular planning software suite. // Image courtesy of Materialise

Materialise, a global 3-D printing software and solutions company based in Belgium with locations in Plymouth Township and Ann Arbor, has received FDA clearance for its Mimics Enlight cardiovascular planning software suite, which was created in collaboration with Detroit’s Henry Ford Health System.

The first release will support clinicians planning complex transcatheter mitral valve replacement procedures.

The software is based on the strengths of Materialise’s Mimics Innovation Suite, which has helped clinicians produce patient-specific 3-D models for more than 20 years. Dr. Dee Dee Wang, director of structural heart imaging at Henry Ford, worked on the solution, which uses the Henry Ford Innovation Institute’s patented workflow. The system is intended to support patient selection and planning for structural heart and vascular therapy.

The software is the first of its kind to include consistent methods of taking critical measurements, allowing clinicians to plan and screen patients for cardiovascular procedures. The transcatheter mitral valve replacement workflow provides a streamlined, easy-to-use clinical workflow for planning procedures to correct mitral regurgitation, a disease affecting nearly one in 10 people aged 75 and older.

“We believe in the power of our mission to create a better and healthier world,” says Bryan Crutchfield, vice president and general manager of Materialise North America. “We work very closely with teams at our partner hospitals and medical device companies to identify areas where 3-D planning and printing can improve their ability to plan procedures. With the FDA clearance of Mimics Enlight, we are expanding the 3-D toolkit for cardiologists working to treat patients with complex cardiovascular issues, starting with mitral valve replacement.”

Each replacement differs due to differences in anatomy, making procedural planning crucial to successfully plant transcatheter mitral valve replacement devices.

“Materialise has a wealth of medical technology and experience built throughout two decades of development and implementation of the Mimics Innovation Suite,” says Brigitte de Vet-Veithen, vice president of Materialise Medical.

“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. Using a 3-D 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.”

Materialise creates software solutions and 3-D printing services in the medical and industrial markets.

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