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SURGICAL VALVE SOLUTIONS

EPIC™ MITRAL AND AORTIC TISSUE VALVES

Exceptional hemodynamic performance, lasting durability, and a design that preserves future valve-in-valve treatment options.

Surgical Valve Solutions

Epic™ Mitral and Aortic Tissue Valves

Epic™ Tissue Valves give your patients exceptional hemodynamic performance, lasting durability, and a design that preserves future valve-in-valve treatment options.

AN EPIC EVOLUTION OF NATURE AND DESIGN

Since 1979, our platform of Epic™ Mitral and Aortic Tissue Valves has combined the best nature has to offer with advanced engineering. Over the decades, minor adjustments to our legacy valve were added gradually, evolving the Epic™ Platform into the innovative porcine tissue valves trusted by physicians today.

Optimized to support future valve-in-valve* interventions

Mitral

  • Low stent post height and natural porcine leaflet behavior to not form a "curtain" may reduce risk of obstructing left ventricular outflow tract (LVOT)
  • Simplified implantation with ratcheting holder to risk of suture looping while offering one-cut release

Aortic

  • Low stent post height may reduce risk of coronary obstruction
  • Natural porcine leaflet behavior to not form a "curtain" may reduce need for risky leaflet modification procedures

     

*Note: The safety and effectiveness of valve-in-valve procedures in an Epic™ Plus or Epic™ Plus Supra valve have not been established.

10 Years

97.3 ± 0.5%

Freedom from
surgery for SVD,
all patient ages
(Epic™ Aortic Valve)2

10 Years

95.7 ± 2.6%

Freedom from
surgery for SVD,
all patient ages
(Epic™ Mitral Valve)2

15 Years

98.4 ± 0.8%

Freedom from
surgery for SVD,
(Epic™ Supra Aortic Valve)3

Hear how an Epic Tissue Heart Valve impacted both Tom and Dana. Getting them back to doing the things that they love.

Patient Aortic Stenosis

Tom

Patient-Epic Max

Dana

The platform for possibility

The Epic™ Platform has been proven over time and defined by strong hemodynamics, intuitive implantability, a future-forward design and more. The platform boasts the low ventricular protrusion in all valve sizes, a flexible polymer stent, individually selected porcine leaflets to ensure optimal coaptation and a flexible sewing cuff designed to minimize both suture drag and paravalvular leak.

  • Epic™ Max Aortic Tissue Valve
    • PORCINE LEAFLETS
    • LOW AORTIC PROTRUSION
    • UNIQUE PERICARDIAL SHIELD
    • LARGE STENT INTERNAL DIAMETER
    • ADAPTIVE CUFF*

    • PORCINE LEAFLETS
      Natural internally mounted leaflet tissue with maximal opening (no muscle bar), complete leaflet coaptation (no central gap), no leaflet curtaining, and less calcification with reduced risk for stroke during reintervention.4

    • LOW AORTIC PROTRUSION
      Mitigates the risk of coronary obstruction and sinus jailing


      Flexfit™ polymer stent

      • Fractures at 8 atm5
      • Eases implant
      • Accommodates minimally invasive surgery

    • UNIQUE PERICARDIAL SHIELD
      Provides a tissue-to-tissue interface to help prevent the risk of abrasion

    • LARGE STENT INTERNAL DIAMETER
      Expands treatment options for patients by facilitating valve-in-valve** procedures with a wide range of Transcatheter Aortic Valve Implantation prostheses

    • ADAPTIVE CUFF*
      Engineered to:

      • Allow maximum flexibility and easy passage through all anatomies
      • Prevent paravalvular leaks by sealing in all planes and minimizes parachuting resistance when delivering the valve onto the annulus valve-in-valve**

    EPIC™ SUPRA AORTIC STENTED TISSUE VALVE FEATURES

    Epic Max
    1
    2
    3
    4
    5

    1. PORCINE LEAFLETS


      Natural internally mounted leaflet tissue with maximal opening (no muscle bar), complete leaflet coaptation (no central gap), no leaflet curtaining, and less calcification with reduced risk for stroke during reintervention.4

    2. LOW AORTIC PROTRUSION


      Mitigates the risk of coronary obstruction and sinus jailing

      FLEXFITTMPOLYMER STENT


      • Fractures at 8 atm5
      • Eases implant
      • Accommodates minimally invasive surgery

    3. UNIQUE PERICARDIAL SHIELD

      Provides a tissue-to-tissue interface to help prevent the risk of abrasion

    4. LARGE STENT INTERNAL DIAMETER

      Expands treatment options for patients by facilitating valve-in-valve** procedures with a wide range of Transcatheter Aortic Valve Implantation prostheses

    5. ADAPTIVE CUFF*

      Engineered to:

      • Allow maximum flexibility and easy passage through all anatomies
      • Prevent paravalvular leaks by sealing in all planes and minimizes parachuting resistance when delivering the valve onto the annulus valve-in-valve**

    *Epic Plus Supra valves offer silicone cuff.

    **The safety and effectiveness of valve-in-valve procedures in Epic Valves has not been established.

  • Epic™ Plus Mitral Tissue Valve
    • Optimal Leaflet Design and Matching
    • Low Ventricular Protrusion
    • FlexFitTM Polymer Stent
    • Unique Pericardial Shield
    • Flexible Cuff
    • Ratcheting Holder

    • OPTIMAL LEAFLET DESIGN AND MATCHING
      Reduces regurgitation risk

    • LOW VENTRICULAR PROTRUSION
      Avoids LVOT obstruction

    • FLEXFITTM POLYMER STENT

      • Withstands approximately 8 atm pressure during balloon valvuloplasty procedures1
      • Eases implant
      • Accommodates MIS procedures.

    • UNIQUE PERICARDIAL SHIELD
      Provides a tissue-to-tissue interface to help prevent the risk of abrasion

    • FLEXIBLE CUFF
      Mitigates PVL and easily fits patient anatomy

    • RATCHETING HOLDER
      Streamlines implant, reduces risk of suture looping, and offers true one cut holder release

    EPIC™ PLUS MITRAL TISSUE VALVE FEATURES

    Epic Plus Supra mitral stented tissue valve features
    1
    2
    3
    4
    5
    6

    1. Optimal leaflet design and matching

      Reduces regurgitation risk

    2. Low ventricular protrusion

      Avoids LVOT obstruction

    3. Flexfit™ polymer stent

      • Withstands approximately 8 atm pressure during balloon valvuloplasty procedures1
      • Eases implant
      • Accommodates MIS procedures.

    4. Unique pericardial shield

      Provides a tissue-to-tissue interface to help prevent the risk of abrasion

    5. Flexible cuff

      Mitigates PVL and easily fits patient anatomy

    6. Ratcheting holder

      Streamlines implant, reduces risk of suture looping, and offers true one cut holder release

  • Low profile design for now and later

    Curtaining is a characteristic of bioprosthetic valves in which the leaflets, when opened, stand tall or form a “curtain” between stent posts. Epic leaflets are not prone to curtaining, which may result in less LVOT obstruction.

    Leaflet behavior when opened

    Epic Plus Valve with representative transcatheter stent inserted

    Mitris Resilia‡ Valve with representative transcatheter stent inserted

    ‡Indicates a third-party trademark, which is property of its respective owner.

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MAT-2001799 v10.0 | Item approved for U.S. use only.

References
  1. Approval Dates on file at Abbott
  2. Jawad, Khalil, Sven Lehmann, Alex Koziarz, Maja Dieterlen, Stefan Feder, Martin Misfeld, Jens Garbade, Vivek Rao, and Michael Borger. “Midterm results after St Jude Medical Epic porcine xenograft for aortic, mitral, and double valve replacement.” Journal of Cardiac Surgery 35, no. 8 (2020): 1769-1777.
  3. Anselmi, Amedeo, et al. "Porcine bioprostheses for surgical aortic valve replacement: very long-term performance of a third-generation device." Journal of Cardiovascular Medicine 24, no. 8 (2023): 514-521.J.
  4. Keshishi, Melanie, et al. “Comparison of Modes of Failure and Clinical Outcomes Between Explanted Porcine and Bovine Pericardial Bioprosthetic Valves.” Cardiovascular Pathology (2023): 107516.
  5. Allen K, et al. Bioprosthetic valve fracture to facilitate transcatheter valve-in-valve implantation. Ann Thorac Surg. 2017;104:1501-1508.
Important Safety Information
  • Epic Plus
  • Epic Max

  • Rx Only

    EPIC™ PLUS/EPIC™ PLUS SUPRA STENTED PORCINE TISSUE VALVES

    INDICATION FOR USE

    The Epic™ Plus valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic and/or mitral heart valve. It may also be used as a replacement for a previously implanted aortic and/or mitral prosthetic heart valve.

    The Epic™ Plus Supra valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic heart valve. It may also be used as a replacement for a previously implanted aortic prosthetic heart valve.

    CONTRAINDICATIONS

    None known.

    POTENTIAL ADVERSE EVENTS

    Adverse events potentially associated with the use of bioprosthetic heart valves (in alphabetical order) include: angina; cardiac arrhythmias; endocarditis; heart failure; hemolysis; hemolytic anemia; hemorrhage, anticoagulant/antiplatelet-related; leak, transvalvular or paravalvular; myocardial infarction; nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other); prosthesis regurgitation; stroke; structural deterioration (calcification, leaflet tear, or other); thromboembolism; valve thrombosis.

    It is possible that these complications could lead to: reoperation; explantation; permanent disability; death.

  • Rx Only

    EPIC™ MAX STENTED PORCINE TISSUE VALVES

    INDICATIONS FOR USE

    The Epic™ Max valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic heart valve. It may also be used as a replacement for a previously implanted aortic prosthetic heart valve. 

    CONTRAINDICATIONS

    None known. 

    POTENTIAL ADVERSE EVENTS

    Adverse events potentially associated with the use of bioprosthetic heart valves (in alphabetical order) include: angina; cardiac arrhythmias; endocarditis; heart failure; hemolysis; hemolytic anemia; hemorrhage, anticoagulant/antiplatelet-related; leak, transvalvular or paravalvular; myocardial infarction; nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other); prosthesis regurgitation; stroke; structural deterioration (calcification, leaflet tear, or other); thromboembolism; valve thrombosis. It is possible that these complications could lead to: reoperation; explantation; permanent disability; death. 

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