Munich Transcatheter Mitral Valve Safety and Effectiveness

"The replacement valve consists of a self-expanding, tri-leaflet, dry bovine -pericardial valve. The dry tissue allows the valve to be conveniently pre-loaded. The key characteristics of Munich valve are:~* Nitinol stent frame~* Bovine pericardium~* Polyester skirt~* Anchoring system allows anchoring the frame to the annulus~* Hooks are used to reduce the mobility of the native leaflets and decrease risk of embolization.~The Munich TMVR system design proposed for this clinical investigation represents a significant evolution from previous TMVR designs:~* Transfemoral / transseptal access~* Self-expanding~* Dry pericardium (can be pre-loaded)~* No anchors~* 27 Fr delivery catheter (~* Sizes: 40/48/55mm~* Height 30 mm The valve is available in 3 sizes with a 30mm profile and has been designed to reduce the complexity of implantation in comparison to other TMVR systems."