Materialise and Henry Ford Health Systems are to bring the healthcare organisation’s mitral planning workflow to a wider Transcatheter Mitral Valve Repair (TMVR) market.
The workflow, which is validated and patented, was developed in Materialise’s Mimics Innovation Suite. Together, the two companies will enter a pre-market phase which will assess the importance of accurate 3D modelling for robust, repeatable patient planning.
Mitral regurgitation, the leaking of blood backwards through the mitral valve when the left ventricle contracts, affects more than 4 million Americans – 10% of which are over the age of 75. The primary option for treatment is open-heart surgery, which puts elderly patients at very high risk and can mean treatment is not carried out. Non-invasive treatment methods are thus being explored, and physicians are recognising the importance of pre-surgical planning. As the pre-market phase commences, Materialise is working with select hospital partners in the U.S. and EU to validate the need for accurate 3D modelling to plan complex TMVR procedures.
“Expanding access to this proven workflow is another step towards our mission to develop innovative products that result in a better and healthier world,” said Brigitte de Vet, Vice President of Medical at Materialise. “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.”
While Materialise is liaising with medical experts in the U.S. and in Europe, organisations participating in the Mitral Valve Planning research program will leverage Henry Ford’s workflow. Here, virtual 3D anatomical models provide the basis for assessing left ventricular outflow tract obstructions (LVOTO) and other elements for planning complex mitral valve procedures.
“The ability to bring advanced 3D computer aided design (CAD) technology and software into the transcatheter mitral space has been a real game changer,” commented Dee Dee Wang, M.D., director of structural heart imaging at Henry Ford Hospital, and medical director, 3D printing, Henry Ford Innovation Institute. “This 3D visualisation of patient specific anatomy can help cardiologists and surgeons gauge each patient’s mitral annular dimensions to better understand how a device will fit in the patient’s heart and the nature of the obstruction of the left ventricular outflow tract (LVOT) for successful TMVR device implants in highly diseased hearts. This, along with proper imaging and skilled staff, brings peri-procedural planning and patient-centred outcomes to a whole new level.”