CARDIOVASCULAR
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Bioprosthetic Heart Valve Sizer Set

Bioprosthetic Heart Valve Sizer Set

PRODUCT HIGHLIGHTS

  • Sizers include annular sizing end for measuring patient’s annulus and Supra sizers include replica end that provides visual and tactile fit in the supra-annular space
  • For use with Epic™, Biocor™, Epic Supra and Biocor Supra valves
  • Tray provides one convenient location for all valve accessories
  • Malleable Nitinol sizer and holder 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, 5 Mitral Sizers, 1 Valve Holder and 1 Autoclavable Tray with Cover (1 unit per box)


Reorder Number Description
B1000 Tissue Valve Sizer Set, Complete
B1000-H Replacement Handle
EX-05  Flexible extension handle. Made of nitinol to provide additional length when used with a holder handle.
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Rx Only

St. Jude Medical Stented Tissue Valves are indicated for use as a replacement for malfunctioning native or prosthetic aortic and/or mitral valves. Adverse events potentially associated with the use of bioprosthetic heart valves include: angina, cardiac arrhythmia, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage (anticoagulant/antiplatelet-related), leak (transvalvular or paravalvular), myocardial infarction, nonstructural dysfunction (e.g., pannus, suture, inappropriate sizing, or other), prosthesis regurgitation, stroke, structural deterioration (e.g., calcification, leaflet tear, or other), thromboembolism and valve thrombosis. It is possible that these complications could lead to reoperation, explantation, permanent disability or death. Long-term anticoagulation and/or anti-platelet therapy should be considered in patients with dilated left atrium, a history of thrombotic events or a cardiac rhythm of atrial fibrillation or flutter. 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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