3D printing firm gets FDA clearance for heart procedure help

PLYMOUTH — Materialise, the Belgian developer of software and services for the 3D printing industry with its North American headquarters in Plymouth, announced that it has received clearance from the U.S. Food and Drug Administration 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 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 using 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 company says the software is the first of its kind to include 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.

Each mitral valve replacement differs due to a patient’s unique anatomy, making procedural planning crucial to the successful implantation of TMVR devices. Accurate measurements during planning are vital for predicting patients’ risk for left ventricle outflow track (LVOT) obstruction, a complication resulting in obstruction of blood flow out of the left ventricle to the rest of the body.

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.

Materialise made the announcement at the Transcatheter Valve Therapies TVT2019 – Structural Heart Summit this week in Chicago.

More at www.materialise.com.

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