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SURGICAL VALVE SOLUTIONS

EPIC™ PLUS MITRAL AND AORTIC STENTED TISSUE VALVES

The latest generation of the Epic™ Platform continues the Epic product family’s history of excellence. The future-forward design of the Epic Plus mitral and aortic valves gives you and your patients more choices when it comes to preserving long-term treatment paths.

SURGICAL VALVE SOLUTIONS

EPIC™ PLUS MITRAL AND AORTIC STENTED TISSUE VALVES

The latest generation of the Epic™ Platform continues the Epic product family’s history of excellence. The future-forward design of the Epic Plus mitral and aortic valves gives you and your patients more choices when it comes to preserving long-term treatment paths.

MADE FOR WHAT’S AHEAD

Built on the proven legacy of its predecessors, the Epic™ Plus valve delivers everything you’ve come to expect from the Epic valve—plus significant improvements to radiopacity and implantability to enable future interventions and implantation for even the most challenging patient anatomies.

MITRAL

  • Low stent post height is less likely to obstruct the left ventricular outflow tract (LVOT)1
  • Epic Plus valve leaflets are not prone to forming a curtain between stent posts when opened; curtaining can result in LVOT obstruction


     
Epic Plus mitral valve has low stent post height

AORTIC

  • Can withstand up to approximately 8 atm pressure during balloon valvuloplasty procedures3
  • Internally mounted leaflets and low stent post height reduce coronary obstruction4
  • Increased visibility at valve annulus and stent posts under fluoroscopy for transcatheter aortic valve replacement (TAVR) procedures
Epic Plus aortic valve for balloon valvuloplasty procedures

*For 27 mm valve size, measured from the farthest point of the cuff.

  • Streamlined customizable implantation
    • Stent symmetry eliminates the need for specific orientation2
    • Flexible polymer stent offers more forgiving insertion and seating
    • Short rinse time of 2 x 10 seconds2
    • Epic Plus Mitral valve ratcheting holder reduces risk of suture looping and offers a true one-cut release
    • Epic Plus Platform cuff options allow for secure suture placement while limiting suture drag and parachuting forces
       
  • Exceptional durability across patient populations

    Linx™ anticalcification (AC) treatment may improve long-term performance and durability.*

    97.3 ± 0.5%†

    FREEDOM FROM
    SURGERY FOR SVD,
    ALL PATIENT AGES
    (Epic Aortic VALVE)5

    95.7 ± 2.6%†

    Freedom from surgery for SVD,
    All patient ages
    (epic mitral valve)5

    98.6 ± 0.8%†

    FREEDOM FROM SURGERY FOR SVD,
    all patient ages
    (Epic Aortic &
    Epic Mitral Valve)5

    *There is no clinical data currently available that evaluates the long-term impact of anticalcification tissue treatment in humans.
    †From stand-alone aortic or mitral valve replacements.
     

Surgical valve treatment for mitral and aortic valve disease

The Epic™ Plus Mitral stented tissue valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native mitral heart valve. It may also be used to replace a previously implanted prosthetic mitral valve.

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

While mitral valve repair is typically the treatment of choice to treat mitral valve dysfunction, it is not always feasible.
 

  • Considerations when selecting bioprosthestic valve candidates7

    A bioprosthetic mitral or aortic valve may be a recommended option for patients under the following AHA/ACC treatment guidelines7:

    • Patients with a contraindication for anticoagulation therapy or an anticipated nonadherence or inability to regulate vitamin K antagonists
    • Patients over 70 years of age
    • For patients 50-65 years of age, there is no clear consensus on choosing a mechanical vs a tissue valve; newer-generation tissue prostheses may show greater freedom from structural deterioration, often for older patients

    Mitral valve replacement

    When repair is not feasible

    • Symptomatic patients with severe primary MR (Stage D)7
    • Asymptomatic patients with severe primary MR and LV systolic dysfunction (LVEF ≤60%, LVESD ≥40 mm) (Stage C2)7
    • Advanced endocarditis9

    Aortic valve replacement

    • Symptomatic adults with severe, high-gradient AS (Stage D1)7
    • Asymptomatic patients with severe AS (Stage C) and either an LVEF <50% or who are undergoing cardiac surgery for other indications7
    • Symptomatic patients with low-flow, low-gradient severe AS with reduced LVEF (Stage D2)7

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 in-implant suture drag and post-implant paravalvular leak.

  • Epic™ Plus Supra aortic stented tissue valve features
    • Silicone-Filled Cuff
    • FlexFitTM Polymer Stent
    • Unique Pericardial Shield
    • Flexible Cuff
    • Low Stent Post Height

    • Allows for supra-annular implantation

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

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

    • Mitigates PVL and easily fits patient anatomy

    • Mitigates risk of coronary obstruction

    EPIC™ SUPRA AORTIC STENTED TISSUE VALVE FEATURES

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

    1. SILICONE-FILLED CUFF

      Allows for supra-annular implantation

    2. FLEXFIT™ POLYMER STENT

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

    3. UNIQUE PERICARDIAL SHIELD

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

    4. FLEXIBLE CUFF

      Mitigates PVL and easily fits patient anatomy

    5. LOW STENT POST HEIGHT

      Mitigates risk of coronary obstruction

  • Epic™ Plus mitral stented tissue valve features
    • Optimal Leaflet Design and Matching
    • Low Ventricular Protrusion
    • FlexFitTM Polymer Stent
    • Unique Pericardial Shield
    • Flexible Cuff
    • Ratcheting Holder

    • Reduces regurgitation risk

    • Avoids LVOT obstruction

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

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

    • Mitigates PVL and easily fits patient anatomy

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

    EPIC™ MITRAL STENTED 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.10,* Epic/Epic Plus Mitral leaflets are not prone to curtaining, which can result in less LVOT obstruction.10,*,†

    Leaflet behavior when opened

    Epic and Epic Plus mitral valve leaflet behavior
    25 mm Epic Mitral† valve (left) and Magna Mitral Ease‡ (right), with representative rods inserted

    *Results based on internal testing.
    †The Epic and Epic Plus valves are designed to the same specifications for dimension and tissue behavior.
    ‡Indicates a third-party trademark, which is property of its respective owner.

  • Preserving the LVOT
    Epic Plus mitral valve stent posts help preserve LVOT
    Epic Plus mitral valve stent post comparison

    *For 27 mm valve size, measured from the farthest point of the cuff.
    †Indicates a third-party trademark, which is property of its respective owner.

  • Anticalcification advantages

    Abbott’s unique Linx AC technology—to promote anticalcification*—is designed to improve long-term performance and valve durability. The Linx AC treatment has demonstrated resistance to calcification by:

    • Extracting lipids13
    • Reducing free aldehydes14,15
    • Minimizing cholesterol uptake16
    • Stabilizing leaflet collagen16


    *No clinical data currently available have evaluated the long-term impact of anticalcification tissue treatment in humans.

MAT-2001799 v8.0 | Item approved for U.S. use only.

References
  1.  Guler N, Ozkara C, Akyol A. Left ventricular outflow tract obstruction after bioprosthetic mitral valve replacement with posterior mitral leaflet preservation. Tex Heart Inst J. 2006;33(3):399-401.
  2. Epic Plus Instructions for Use.
  3. Allen KB, Adnan CK, Cohen DJ, et al. Bioprosthetic valve fracture to facilitate transcatheter valve-in-valve implantation. Ann Thorac Surg. 2017;104:1501-1508.
  4. Edelmann JJ, Khan JM, Rogers T, et al. Valve-in-valve TAVR: state-of-the-art review. Innovations. 2019;14(4):299-310.
  5. 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.
  6. Adams DH, Rosenhek R, and Falk V. Degenerative mitral valve regurgitation: best practice revolution. Eur Heart J. 2010;31(16):1958-1967. doi:10.1093/eurheartj/ehq222.
  7. Otto, Catherine M., Rick A. Nishimura, Robert O. Bonow, Blase A. Carabello, John P. Erwin III, Federico Gentile, Hani Jneid et al. "2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines." Journal of the American College of Cardiology 77, no. 4 (2021): 450-500.
  8. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC Guideline for the management of patients with valvular heart disease. Circulation. 2014;129(23):2240-2492.
  9. Mick SL, Keshavamurthy S, Gillinov AM. Mitral valve repair vs replacement for the management of valvular heart disease. Eur Heart J. 2017;38:2739-2791.
  10. Tests performed by and data on file at Abbott.
  11. Magna Mitral Ease Instructions for Use.
  12. Medtronic Mosaic Bioprosthesis Aortic and Mitral Brochure. #UC200103933b EN.
  13. Vyavahare, N, Hirsch, D, Lerner, E, et al. Prevention of bioprosthetic heart valve calcification by ethanol preincubation. Circulation. 1997:95;479-488. doi.org/10.1161/01.CIR.95.2.479.
  14. Kelly SJ, Ogle MF, Carlyle WC, et al. Biocompatibility and calcification of bioprosthetic heart valves. Presented at: Society for Biomaterials, Sixth World Biomaterials Congress Transaction. May 2000:1353.
  15. Frater RWM, Seifter E, Liao K, et al. Chapter 8. In: Gabbay, S, Wheatley DJ, eds. Advances in Anticalcific and Antidegenerative Treatment of Heart Valve Bioprostheses. 1st ed. Silent Partners, Inc; 1997:105-113.
  16. Vyavahare NR, Hirsch D, Lerner E, et al. Prevention of calcification of glutaraldehyde-crosslinked porcine aortic cusps by ethanol preincubation: mechanistic studies of protein structure and water-biomaterial relationships. J Biomed Mater Res. 1998;40:577-585.
Important Safety Information

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.

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