Software enables accurate 3D planning for cardiac procedures
The Food and Drug Administration has provided clearance for a suite of software for planning complex cardiovascular procedures.
In announcing the FDA clearance, Chicago-based Materialise says the first release of the software will support clinicians who are planning complex transcatheter mitral valve replacement (TMVR) procedures.
The company offers 3D printing software and solutions, and it worked in collaboration with the Henry Ford Health System in Detroit on the product, called Mimics Enlight. The new product is intended to support patient selection and planning for structural heart and vascular therapy.
The initiative with Henry Ford involved Dee Dee Wang, MD, director of structural heart imaging in the organization, and leveraged the patented workflow of the Henry Ford Innovation Institute.
Materialise and Henry Ford executives say the software is the first of its kind to include consistent methods of taking critical measurements, enabling 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 because of 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 obstruction, a complication resulting in obstruction of blood flow out of the left ventricle to the rest of the body.
“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,” says Bryan Crutchfield, vice president and general manager of Materialise. “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 company’s executives say that 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.
Leveraging Materialise’s expertise in creating accurate patient-specific 3D anatomical models, 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.