Mosaic Ultra® Aortic Heart Valve with Cinch® II Implant System
The Mosaic Ultra Aortic Heart Valve is a stented bioprosthesis designed specifically for aortic valve replacement. Medtronic's innovative AOA® tissue treatment mitigates calcification, while Physiologic Fixation maintains leaflet form and function. The Cinch Implant System aids in valve insertion, particularly through a tight sinotubular space, and facilitates tying behind the stent posts.
- Aortic bioprosthetic, designed specifically for the small aortic root
- Reduced sewing cuff maximizes valve-to-annulus ratio
- AOA tissue treatment is designed to mitigate calcification, while Physiologic Fixation maintains the natural leaflet form and function.
Important Safety Information
Adverse events potentially associated with the use of bioprosthetic heart valves include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic, anemia, hemorrhage (anticoagulant/antiplatelet-related), leak (transvalvular or paravalvular), myocardial infarction, nonstructural dysfunction (obstructive pannus ingrowth, suture dehiscence, inappropriate sizing, other), stroke, structural deterioration (calcification, leaflet tear, other), thromboembolism, valve thrombosis. It is possible that these complications could lead to: reoperation, explantation, permanent disability, or death.
No clinical data are available which evaluate the long-term impact of the Physiological Fixation process or AOA tissue treament in patients.
Please ask your Medtronic Sales Representative if this product is available in your geography.
