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June 17, 2019

FDA clears Materialise’s cardiovascular planning software

3D printing solutions provider Materialise has obtained clearance for its Mimics Enlight cardiovascular planning software suite from the US Food and Drug Administration (FDA).

3D printing solutions provider Materialise has obtained clearance for its Mimics Enlight cardiovascular planning software suite from the US Food and Drug Administration (FDA).

Initially, the suite will be available for clinicians to plan complex transcatheter mitral valve replacement (TMVR) procedures.

Mimics Enlight builds on the company’s Mimics Innovation Suite, which enables generation of patient-specific 3D models. The new product is designed to support patient selection and planning for structural heart and vascular therapy.

In addition, the software features consistent approaches for taking important measurements required by clinicians to plan and screen patients for cardiovascular procedures.

The TMVR suite offers an easy-to-use clinical workflow for planning complex procedures to correct mitral regurgitation, which is known to impact around one in ten people aged 75 years and older.

Procedural planning for TMVR device implantation is considered important as each mitral valve replacement differs between patients.

The company noted that accurate measurements during planning are needed to predict a patients’ risk for left ventricle outflow track (LVOT) obstruction.

In TMVR procedures, Mimics Enlight Mitral is intended to provide clinicians with accurate 3D models for consistent measurements such as Neo-LVOT to screen patients, plan procedures and decide on the right size and positioning of implants.

Materialise North America vice-president and general manager Bryan Crutchfield said: “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.”

The software suite was developed in alliance with Henry Ford Health System in Detroit.

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