FDA clears CV planning software suite from Materialise

Global 3D printing company Materialise on June 13 announced its Mimics Enlight cardiovascular planning software suite received FDA clearance and will soon be rolled out to clinicians.

According to a statement from Materialise, Mimics Enlight builds on one of the company’s earlier successes, the Mimics Innovation Suite, but is the first software of its kind to include consistent methods of taking critical measurements. Mimics Enlight is intended to support patient selection and procedural planning for structural heart and vascular therapies, and its first release will support clinicians planning complex transcatheter mitral valve replacements (TMVRs).

In its statement, Materalise calls its latest product “a streamlined, easy-to-use clinical workflow for planning complex procedures to correct mitral regurgitation.” Since each mitral valve replacement will differ depending on an individual’s unique anatomy, accurate measurements are key, making the manual planning process for such procedures tedious.

Mimics Enlight Mitral solves the problem with accurate patient-specific 3D anatomical models and measurements that make it easier for clinicians to plan TMVRs and determine the appropriate size and positioning of TMVR devices.

“We believe in the power of our mission to create a better and healthier world,” Bryan Crutchfield, vice president and general manager of Materalise North America, said in the statement. “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.”