Materialise said today that FDA has provided 510(k) clearance for its Mimics Enlight — a cardiovascular procedure planning software creating accurate 3D printed heart models.
The Belgian 3D printing software and services company, which has its U.S. offices in Plymouth, Minn., plans the first release of the software to focus on planning for complex transcatheter mitral valve replacement (TMVR) procedures.
Drawing on Materialise’s ability to create patient-specific 3D anatomical models, Mimics Enlight Mitral can provide clinicians with accurate 3D models for consistency in taking measurements such as Neo-LVOT to screen patients for TMVR therapy. The models can assist surgeons in planning procedures and determining the appropriate size and positioning of TMVR devices. The tasks are important because each patient’s heart anatomy is unique.
“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,” Bryan Crutchfield, VP and general manager of Materialise North America, said in a news release.
More than a year ago, Materialise won FDA clearance for its Mimics inPrint software, which supports 3D printing of anatomical models for diagnostic use.
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