Epic™ Stented Tissue Valve with Linx™ AC Technology

This device is commercially available for use in the United States and select international markets.

Redefining Performance Through Implant & Durability

The Epic Stented Tissue Valve with Linx AC Technology offers the same design as the Biocor™ Valve, a bioprosthetic heart valve which is supported by 20 years of published durability data and 25 years of clinical experience.

With Linx™ AC Technology

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 which evaluates the long-term impact of anti-calcificaiton tissue treatment in humans.  

Features & Benefits

Linx AC Technology

Linx AC Technology is a patented, proprietary valve treatment that significantly reduces calcification in animal studies.*

Rat Subdermal Study (60 days) shows 99% reduction in calcification.

 Epic Stented Tissue Valve Link AC

Linx AC Technology in animal studies has been demonstrated to resist calcification in four ways:


 

 

Designed for Durability

  • Triple Composite Design: Features three separate porcine leaflets matched to optimize leaflet coaptation and reduce stress 

 Epic Stented Tissue Valve Triple Composite Design

 

  • Unique Pericardial Shield On Outflow Edge: Helps prevent risk of abrasion by providing tissue-to-tissue interface

 Epic Stented Tissue Valve Pericardial Shield

 

FlexFit™ System

  • FlexFit™ Mitral Ratcheting System: Provides stent deflection and maximizes visibility and access to cuff
  • FlexFit™ Mitral and Aortic Holder: Improve visibility and cuff access
  • FlexFit™ 20 Second Rinse: Reduced to a 2 x 10 second rinse
  • FlexFit™ Valve Sizers and System Tray: Click-in handle and leading sizer design

 Epic Stented Tissue Valve FlexFit

 

References

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.

2Frater 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.

3 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.

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.

Supra (Aortic)

 Epic Stented Tissue ValveSupraaortic

Model # Valve Size(mm) Tissue Annulus Diameter(mm) Internal Diameter (Stent 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

 

Aortic

Epic Stented Tissue Valve Aortic

Model # Valve Size (mm) Tissue Annulus Diameter(mm) Internal Diameter (Stent mm) Aortic Protrusion(mm)  Total Height (mm)
ESP100-21A-00   21  21  19  9  14
ESP100-23A-00  23  23  21  9  15
ESP100-25A-00  25  25  23  10  16
ESP100-27A-00   27  27  25  11  17
ESP100-29A-00   29  29  27  13  19

 

Mitral

Epic Stented Tissue Valve Mitral 

Model # Valve Size (mm) Tissue Annulus Diameter(mm) Internal Diameter (Stent mm) Aortic Protrusion(mm) Total Height (mm)
ESP100-27M-00  27  27  25  9  17
ESP100-29M-00   29  29  27  10  19
ESP100-31M-00   31  31  29  10  20
ESP100-33M-00   33  33  31  11  20

Product Demonstration Epic Valve with Linx AC Animation

Linx AC Animation: The Science Behind the Technology.

 

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