CARDIOVASCULAR
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Trifecta™ Valve Sizer Set

Trifecta<sup>™</sup> Valve Sizer Set

PRODUCT HIGHLIGHTS

  • Designed to facilitate proper size selection of the Trifecta tissue valve
  • Sizes 19 mm – 29 mm
  • The cylindrical end determines the appropriate size of the annulus
  • The corresponding valve replica end is used to visualize supra-annular placement
  • Features click-in handle for quick attachment to valve holder
  • Malleable Nitinol sizer and handle can be bent in any direction (up to 90 degrees) without degradation
  • Sizer and holder handle return to original, straight shape during sterilization

ORDERING INFORMATION

Contents: 6 Double-ended Aortic Sizers, 1 Valve Holder Handle and 1 Autoclavable Tray with Cover (1 unit per box)


Reorder Number Description
TF2000 Trifecta Valve Sizer Set, Complete
UT2000 Flexible Holder Handle
UT2000-R Rigid Holder Handle
EX2000-R  Rigid extension handle. Made of stainless steel to provide additional length when used with a holder handle.
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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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