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EpicTM Stented Valve with LinxTM AC Technology
ST. JUDE MEDICAL, INC.
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One Lillehei Plaza |
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Supported by 20-year published durability data for our Biocor™ Valve and 25 years of Biocor clinical experience, the Epic Valve offers the same design as the Biocor Valve, with Linx AC Technology. A patented, proprietary anti-calcification treatment, Linx AC is designed to improve long-term performance and valve durability.*
For enhanced control during the entire implant procedure, the Epic Valve also features the exclusive FlexFit™ System.
*There is no clinical data currently available that evaluates the long-term impact of anti-calcification tissue treatment in humans.
PRODUCT FEATURES
- LinxTM AC Technology
LinxTM AC Technology is a patented, proprietary valve treatment that significantly reduces calcification in animal studies.1 LinxTM AC Technology has been demonstrated to resist calcification by reducing free aldehydes3,4, extracing lipids2 and minimizing uptake of cholestrol5 - Designed for Durability
• The triple composite design features three separate porcine leaflets matched to optimize leaflet coaptation and reduce stress
• A unique pericardial shield on outflow edge helps prevent risk of abrasion by providing tissue-to-tissue interface - The FlexFitTM System
• FlexFitTM Mitral Ratcheting System: Provides stent deflection and maximizes visibility and access to cuff
• FlexFitTM Mitral and Aortic Holder: Improve visibility and cuff access
• FlexFitTM 20 Second Rinse: Reduced to a 2 x 10 second rinse
• FlexFitTM Valve Sizers and System Tray: Click-in handle and leading sizer design - References:
1 Rat Subdermal Study (60 days) shows 99% reduction in calcification.
2 Vyavahare N, Hirsch D, Lerner E, Baskin JZ, Schoen FJ, Bianco R, Kruth HS, Zand R, Levy RJ. Prevention of Bioprosthetic Heart Valve Calcification by Ethanol Preincubation. Circulation 1997;95:479-488.
3 Frater RWM, Seifter E, Liao K, Wasserman F. Advances in Anticalcific and Antidegenerative Treatment of Heart Valve Bioprostheses. Edited by Gabbay S, and Wheatley D. First Edition, Silent Partners, Inc. 1997;8:105-113.
4 Kelly SJ, Ogle MF, Carlyle WC, Mirsch MW. Biocompatibility and Calcification of Bioprosthetic Heart Valves. Society for Biomaterials, Sixth World Biomaterials Congress Transaction, 2000;1353.
5 Vyavahare N, Hirsch D, Lerner E, Baskin J, Zand R, Schoen F, Levy R. Prevention of calcification of glutaraldehyde-crosslinked porcine aortic cusps by ethanol preincubation. J Biomed Mater Res, 1998;40:577-585.