CARDIOVASCULAR
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Biocor™ Stented Tissue Valve

Biocor<sup>™</sup> Stented Tissue Valve

PRODUCT HIGHLIGHTS

  • Delivers proven 20-year durability results1,2
  • 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™ mitral valve holder provides stent deflection (ratcheting), which reduces the potential for suture looping and maximizes visibility and access to the valve cuff
  • Low combined valve and holder height facilitates minimally invasive surgical procedures
  • Low-profile design reduces the risk of LV outflow tract obstruction
  • FlexFit stent reduces leaflet stress, adapts easily to annulus to enhance knot positioning, and returns stent posts to original shape after deflection
  • Short 2 x 10-second rinse time

ORDERING INFORMATION

Contents: Mitral Stented Tissue Valve (1 unit per box)


Reorder Number Valve Size (mm) Tissue Annulus Diameter (mm) Internal Diameter (mm) Ventricle Protrusion (mm) Total Height (mm)
B100-25M-00 25 25 23 9 16
B100-27M-00 27 27 25 9 17
B100-29M-00 29 29 27 10 19
B100-31M-00 31 31 29 10 20
B100-33M-00 33 33 31 11 20

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: December 05, 2018

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