Mimics Enlight Cardiovascular Planning Software Gets FDA Clearance

Materialise, a 3D printing company with a focus on patient-specific parts, has received FDA clearance for its Mimics Enlight cardiovascular planning software suite. The product’s initial application will be in planning complex transcatheter mitral valve replacement (TMVR) procedures.

Developed with the help of the Henry Ford Health System in Detroit, and in particular Dr. Dee Dee Wang, MD, FACC, Director of Structural Heart Imaging at the hospital, the Mimics Enlight software lets cardiologists identify which patients are appropriate for treatment and measures various important parameters to make sure that a given procedure is a success. Though the software can be used for a variety of structural heart and vascular therapy approaches, it is initially intended to be used to help treat mitral regurgitation through the transcatheter placement of prosthetic valves over diseased valves.

Because of the unique nature of each patient’s anatomy around the mitral valve, selecting the right prosthetic valve and placing it in the correct location is not a trivial task. Left ventricular outflow track obstruction is the primary potential side effect of TMVR, a serious condition that can severely affect the flow of blood through and around the heart. Accurate measurements can provide cardiologists with the confidence necessary to implant mitral valves, something that still remains quite difficult and is therefore performed in only a few institutions around the world.

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Product page: Mimics Enlight…

Via: Materialise