Materialise Receives FDA Clearance for Cardiovascular Planning Software Suite

Materialise has received FDA clearance for its Mimics Enlight cardiovascular planning software suite. The first release will support clinicians planning complex transcatheter mitral valve replacement (TMVR) procedures.

Mimics Enlight is based on the strengths of Materialise's Mimics Innovation Suite, which has helped clinicians produce patient-specific 3D models for more than 20 years. Created in collaboration with Henry Ford Health System in Detroit with Dr. Dee Dee Wang, MD, FACC, director of Structural Heart Imaging, and leveraging the Henry Ford Innovation Institute's patented workflow, Mimics Enlight is intended to support patient selection and planning for structural heart and vascular therapy.

The software includes consistent methods of taking critical measurements. This enables clinicians to reliably plan and screen patients for cardiovascular procedures. The TMVR workflow provides a streamlined, easy-to-use clinical workflow for planning complex procedures to correct mitral regurgitation, a disease affecting nearly one in 10 people age 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 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."

"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.

Leveraging Materialise's expertise in creating accurate patient-specific 3D anatomical models, Mimics Enlight Mitral gives clinicians accurate 3D models for consistency in taking measurements like Neo-LVOT to screen patients for TMVR therapy, plan procedures and determine the appropriate size and positioning of TMVR devices, according to Materialise.

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