Materialise, a 3D printing software and solutions company, has received the US Food and Drug Administration (FDA) clearance for its Mimics Enlight cardiovascular planning software suite.
Materialise said that the first release of its software suite will support clinicians in planning complex transcatheter mitral valve replacement (TMVR) procedures.
The company has designed the Mimics Enlight in collaboration with Henry Ford Health System structural heart imaging director Dr. Dee Dee Wang. It is based on the strengths of its Mimics Innovation Suite, which has helped clinicians produce patient-specific 3D models for more than 20 years.
In addition, the device was created leveraging the patented workflow of Henry Ford Innovation Institute and is intended to support patient selection and planning for structural heart and vascular therapy.
Materialise North America vice president and general manager Bryan Crutchfield said: “We believe in the power of our mission to create a better and healthier world. 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.”
Materialise claims that the Mimics Enlight marks the first software to include consistent methods of critical measurements, enabling clinicians to plan and screen patients for cardiovascular procedures more reliably.
The TMVR workflow provides an updated, easy-to-use clinical workflow for planning complex procedures in correcting the mitral regurgitation, a cardiovascular disease.
Based on the patient’s unique anatomy, each mitral valve replacement requires procedural planning for implantation of TMVR devices, where accurate measurements during planning play key role in predicting risk for left ventricle outflow track (LVOT) obstruction.
LVOT obstruction is a complication that results in obstruction of blood flow out of the left ventricle to the rest of the body.
Materialise Medical vice president Brigitte de Vet-Veithen said: “Materialise has a wealth of medical technology and experience built throughout two decades of development and implementation of the Mimics Innovation Suite.That expertise in delivering patient-specific solutions serves as the foundation for Mimics Enlight Mitral’s ability to consistently view and measure each patient’s complex mitral valve anatomy.
“Using a 3D model created in Mimics Enlight Mitral improves physicians’ ability to understand and plan procedures before entering the cath lab and gives them the reliable measurements critical to successful implantation of TMVR devices in highly diseased hearts.”