CARDIOVASCULAR
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Trifecta™ Valve

Trifecta Valve

PRODUCT HIGHLIGHTS

  • Exceptional hemodynamic performance1
  • Exterior-mounted pericardial leaflets with unique suture attachment allows for maximum leaflet excursion and larger EOAs2
  • Designed to provide excellent durability with the pericardial-covered stent for tissue-to-tissue contact to reduce the risk of abrasion
  • Includes Linx™ AC Technology, which is designed to improve long-term performance and valve durability*
  • Designed to maintain structural integrity with a high-strength, fatigue-resistant, titanium alloy stent2
  • Short 2 x 10-second rinse time

ORDERING INFORMATION


Reorder Number Valve Size (mm) Tissue Annulus Diameter (mm) Cuff Outer Diameter (mm) Aortic Protrusion (mm) Total Height (mm)
TF-19A 19 19 24 12 15
TF-21A 21 21 26 13 16
TF-23A 23 23 28 13 17
TF-25A 25 25 31 14 18
TF-27A 27 27 33 15 19
TF-29A 29 29 35 16 20

1. St. Jude Medical. Trifecta Valve, Pre-Market Approval Application Summary of Safety and Effectiveness Data, P100029, 2011.

2. St. Jude Medical. Data on File.


Rx Only

Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications: The Trifecta Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve. Adverse events potentially associated with the use of bioprosthetic heart valves include: angina, cardiac arrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, leak (transvalvular or perivalvular), myocardial infarction, nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other), prosthesis regurgitation, stroke, structural deterioration (calcification, leaflet tear, perforation, or other), thromboembolism and valve thrombosis. It is possible that these complications could lead to reoperation, explantation, permanent disability or death. Long-term low dose aspirin, unless contraindicated, is recommended for all patients with bioprosthetic valves. Long-term anticoagulant therapy, unless contraindicated, is recommended for all patients with bioprosthetic valves who have risk factors for thromboembolism. Please see the Instructions for Use (IFU) for a full description of indications, contraindications, side effects, precautions, warnings and Instructions for Use.

100033292 – May 2012

Last Updated: January 02, 2019

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