Materialise announce pre-market phase of development for mitral valve planning
Mitral regurgitation affects more than 4 million Americans – nearly one in 10 people aged 75 or older. Currently the primary option for the disease is open-heart surgery, which holds extremely high risks for patients in this age group and can prevent treatment in many cases. Non-invasive methods are entering the market to address this need and physicians are recognizing the importance of pre-surgical planning for this complex disease. Entering their pre-market phase of development, Materialise is working with select U.S. and EU hospital partners to validate the importance of accurate 3D modeling to help physicians plan complex transcatheter mitral valve replacement & repair (TMVR/r) procedures.
The pre-market phase will assess the importance of accurate 3D modeling for robust, repeatable patient planning. Materialise has partnered with Henry Ford Health Systems to bring Henry Ford’s validated, patented, mitral planning workflow, developed in Materialise’s Mimics Innovation Suite to a broader TMVR Market.“Expanding access to this proven workflow is another step towards our mission to develop innovative products that result in a better and healthier world. Working with specific hospital partners in this pre-market phase of development of a TMVR planning tool means we are one step closer to helping more patients receive therapy without the risks inherent to open-heart surgery.”said Brigitte de Vet, Vice President of Medical at Materialise.
Materialise software enables customized workflows through scripting capabilities to streamline processes. Organizations participating in the Mitral Valve Planning research program will leverage Henry Ford’s validated workflow in Materialise’s Mimics Innovation Suite software where virtual 3D anatomical models are the basis for assessing left ventricular outflow tract obstructions (LVOTO) and other elements for planning complex mitral valve procedures.
“The mitral valve anatomy is much more complex than other areas of the heart that transcatheter devices currently treat. The ability to bring advanced 3D computer aided design (CAD) technology and software into the transcatheter mitral space has been a real game changer. said Dee Dee Wang, M.D., director of structural heart imaging at Henry Ford Hospital, and medical director, 3D printing, Henry Ford Innovation Institute.