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FDA approves Materialise’s Mimics Enlight software for cardiovascular planning

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Materialise has made a further inroad into the medical market with recent FDA clearance for its Mimics Enlight cardiovascular planning software suite. The software tools are designed to support clinicians in the planning of complex transcatheter mitral valve replacement (TMVR) procedures.

Belgium-based Materialise has played an important role in the additive manufacturing industry for the past three decades—especially on the software front. The company’s Mimics Innovation Suite has been used by clinicians for over 20 years to enable the production of patient-specific 3D printed models. The recently approved Mimics Enlight suite is based on these well-established tools with a special focus on planning structural heart and vascular therapies.

The software was developed in collaboration with Henry Ford Health System in Detroit with Dr. Dee Dee Wang, MD, FACC, Directory of Structural Heart Imaging. The Mimics Enlight suite leverages the Henry Ford Innovation Institute’s patented workflow and is specially developed to enable patient selection and planning for TMVR and similar operations.

Mimics Enlight is reportedly the first software to include consistent methods for taking critical measurements—a feature that ensures clinicians can plan and screen patients for cardiovascular procedures in a consistent and reliable way. Because each mitral valve replacement is patient-specific, it is critical to have accurate measurements in the planning stages in order to predict potential complications, such as left ventricle outflow track (LVOT) obstruction.

Materialise Mimics Enlight FDA

The software is also designed for ease-of-use, with a streamlined workflow for planning out complex procedures for correcting mitral regurgitation, a disease that affects about 10% of people over the age of 75.

“We believe in the power of our mission to create a better and healthier world,” commented 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 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.”

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

The accurate and patient-specific 3D models generated in Materialise’s Mimics Enlight software facilitate the screening of patients for TMVR therapy as well as procedure planning, including finding the right size and positioning of TMVR devices.

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Tess Boissonneault

Tess Boissonneault is a Montreal-based content writer and editor with five years of experience covering the additive manufacturing world. She has a particular interest in amplifying the voices of women working within the industry and is an avid follower of the ever-evolving AM sector. Tess holds a master's degree in Media Studies from the University of Amsterdam.

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