CARDIOVASCULAR
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Epic™ Supra Stented Tissue Valve with Linx™ AC Technology

Epic<sup>™</sup> Supra Stented Tissue Valve with Linx<sup>™</sup> AC Technology

PRODUCT HIGHLIGHTS

  • Provides a larger stent-to-annulus ratio than Epic aortic valve
  • Identical in design to the Biocor™ Supra stented tissue valve, which delivers proven 20-year durability results1,2
  • Includes Linx AC Technology, which is designed to improve long-term performance and valve durability*
  • Three separate porcine leaflets are matched to optimize leaflet coaptation and reduce stress
  • The outflow edge is covered with a pericardial shield, providing a tissue-to-tissue interface to reduce the risk of abrasion
  • FlexFit™ stent reduces leaflet stress, adapts easily to annulus to enhance knot positioning, and returns stent posts to original shape after deflection
  • Low-profile design provides optimal coronary ostia clearance
  • Short 2 x 10-second rinse time

ORDERING INFORMATION

Contents: Aortic Supra-Annular Stented Tissue Valve (1 unit per box)


Reorder Number Valve Size (mm) Tissue Annulus Diameter (mm) Internal Diameter (mm) Aortic Protrusion (mm) Total Height (mm)
ESP100-19-00 19 19 19 11 14
ESP100-21-00 21 21 21 11 15
ESP100-23-00 23 23 23 13 16
ESP100-25-00 25 25 25 13 17
ESP100-27-00 27 27 27 14 19
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* There is no clinical data currently available that evaluates the long-term impact of anticalcification tissue treatment in humans.

1. Myken PS, Bech-Hansen O. A 20-year experience of 1712 patients with the Biocor porcine bioprosthesis. J Thorac and Cardiovasc Surg. 2009;137(1):76-81.

2. Eichinger WB, Hettich IM, Ruzicka DJ, et al. Twenty-year experience with St. Jude Medical Biocor bioprosthesis in the aortic position. Ann Thorac Surg. 2008;86(4):1204-1210.


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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