Cinch® II engineering advancements for an implantability advantage.
Cinch® II Implant System deflects the stent posts inward and holds them in place during implant. This allows visibility of the sewing ring in tight spaces (i.e., small incisions, tight roots), which is not always possible with other tissue valve substitutes when working with difficult patient anatomies.
POTENTIAL ADVERSE EVENTS
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
- Death
Mosaic® Porcine Bioprosthesis
Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Contraindications: None known. Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis. For additional information, please refer to the Instructions For Use provided with the product. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
Hancock® II Bioprosthesis
Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Contraindications: None known. Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis. For additional information, please refer to the Instructions For Use provided with the product. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
Mosaic, Hancock, and Cinch are registered trademarks of Medtronic, Inc.