Mosaic and Mosaic Ultra

Summary

Exclusive Third Generation Technology Featuring Cinch Implant System

Mosaic^® and Mosaic Ultra^® Bioprostheses offer implantability, durability, and improved hemodynamics.

Implantability

• Cinch^® Implant System facilitates aortic valve insertion, particularly through a tight sinotubular space and helps prevent suture “looping” around stent posts for mitral valve replacement.
• Flexible stent reduces tissue stress.
• Especially suited for minimally invasive procedures

Durability

• Thirteen-year results demonstrate clinical safety and excellent performance.¹
• AOA^® Tissue Treatment helps mitigate valve calcification.²
• Physiologic Fixation™ Process preserves leaflet structure and provides leaflets that function similarly to native aortic valves.^3,4

Hemodynamics

• Leaflets open physiologically for excellent forward flow.⁵
• Designed by nature to minimize backflow and prevent regurgitation.
• The Mosaic Ultra has a reduced sewing cuff that allows greater flexibility to implant a larger valve size for improved hemodynamics. Its scalloped sewing ring conforms to the aortic annulus for complete supra-annular placement.

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.

For additional information, please refer to the Instructions for Use provided with the product.