Epic™ with Linx AC Technology

Advanced Technology for Long-Term Durability

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.

             

 

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

              

Designed for Durability

  • Triple Composite Design: Three separate porcine leaflets are matched to optimize leaflet coaptation and reduce stress.

           

 

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

The 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 & System Tray: Click-in handle and leading sizer design 

  •  FlexFit™ Package Labeling: Quick, intuitive identification

                                       

 

References:

1. 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.

2. 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.

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.

4. 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.

 

Safety & Indications

Non-clinical testing has demonstrated that St. Jude Medical® heart valves and repair devices are MR Conditional. They can be scanned safely under the following conditions:

  • Static magnetic field of 3 Tesla or less
  • Spatial gradient of 325 Gauss/cm or less
  • Maximum whole-body-averaged specific absorption rate (SAR) of 2.0-W/kg for 15 minutes of scanning
In non-clinical testing, St. Jude Medical valves and repair devices produced a temperature rise of less than or equal to 0.5˚ C at a maximum whole body-averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR scanning in a 3-Tesla Signa model (GE) MR scanner. MR image quality may be compromised if the area of interest is the exact same area or relatively close to the position of the device.

Reimbursement Information

Related Materials

Product Components

Demonstration Video

Technical Specifications

Sizes and Reference Dimensions*:

Supra (aortic)

Model No.

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

Model No.

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

 12

19

 

Mitral

Model No.

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

Request More Information

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