Mitral Valve Disease is the most frequent structural heart disease next to aortic valve stenosis. There are 500,000 annual diagnoses of severe MR in the US and Europe, of which only about 20% are treated surgically, the 80% of patients remain with subotimal treatment.
The transcatheter mitral valve replacement devices currently developed show several limitations: the conventional radial shrinking of the devices requires delivery systems with big diameters. This leads to higher complication rates in morbidity and mortality by access bleeding, atrial septum defects and deployment problems.
Open Stent Solution is positioned to overcome those limitations by revolutionizing the delivery and deployment method of the device by longitudinal alignment of the stent.
Open Stent Solution is suitable for all types of mitral valve defects and will make the percutaneous treatment safer and more effective. The Open Stent Solution device will primarily be used to treat mitral valve regurgitation in high-risk patients to prevent heart failure development.