Materialize today said the FDA has granted 510(k) clearance for its Mimics Enlight, a cardiovascular procedure planning software that creates accurate 3D printed heart models.
The Belgian 3D printing software and services company, which has its US offices in Plymouth, Minnesota, plans the first release of the software to focus on planning complex Transcatheter Mitral Valve Replacement (TMVR) procedures ).
Leveraging Materialize’s ability to create patient-specific 3D anatomical models, Mimics Enlight Mitral can provide clinicians with accurate 3D models to ensure consistency in measurements such as Neo-LVOT to screen patients for TMVR therapy. Models can help surgeons plan procedures and determine the appropriate size and placement of TMVR devices. The tasks are important because each patient’s cardiac anatomy is unique.
“We are working closely with teams at our partner hospitals and medical device companies to identify areas where planning and 3D printing can improve their ability to plan procedures. With FDA clearance for Mimics Enlight, we are expanding the 3D toolkit for cardiologists working to treat patients with complex cardiovascular conditions, beginning with mitral valve replacement,” said Bryan Crutchfield, Vice president and CEO of Materialize North America, in a press release.
More than a year ago, Materialize obtained FDA clearance for its Mimics inPrint software, which supports 3D printing of anatomical models for diagnostic purposes.