Epic™ Plus Mitral and Aortic
Stented Tissue Valves

EVEN MORE EPIC

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 lowest 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

FlexFit™ 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

  • Streamlines implant and reduces risk of suture looping

  • Mitigates risk of coronary obstruction

EPIC™ PLUS SUPRA AORTIC STENTED TISSUE VALVE FEATURES

EPIC™ SUPRA AORTIC STENTED TISSUE VALVE FEATURES
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  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

FlexFit™ 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™ PLUS MITRAL STENTED TISSUE VALVE FEATURES

EPIC™ MITRAL STENTED TISSUE VALVE FEATURES
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  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

FLEXIBLE DESIGN 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.2* Epic™ / Epic™ Plus valve leaflets are not prone to curtaining, which can result in less LVOT obstruction.2*†

Leaflet BEHAVIOR when opened

*Results based on internal testing.
The Epic and Epic Plus valves are designed to the same specifications for dimension and tissue behavior.

 


 

LEAFLET BEHAVIOR
PORCINE VS. PERICARDIAL SURGICAL VALVES

 

  • Bapat, et al.3

    “In the bench test, we observed that the pericardial leaflets stand tall unlike the porcine leaflets which crumple. This will result in greater degree of LVOT obstruction with pericardial leaflets.”
     

PRESERVING THE LVOT


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

.
 

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 lipids8
  • Reducing free aldehydes9,10
  • Minimizing cholesterol uptake11
  • Stabilizing leaflet collagen11

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

    MAT-2001799 v4.0 | Item approved for U.S. use only.

    References
    1. 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.
    2. Tests performed by and data on file at Abbott.
    3. Bapat V, Pirone F, Kapetanakis S, et al. Factors influencing left ventricular outflow tract obstruction following a mitral valve-in-valve or valve-in-ring procedure, part 1. Catheterization and Cardiovascular Interventions. 2015;86:747-760.
    4. Guler N, Ozkara C, Akyol A, et al. Left ventricular outflow tract obstruction after bioprosthetic mitral valve replacement with posterior mitral leaflet preservation. Texas Heart Institute Journal. 2006;33:399-401.
    5. Epic Plus Instructions for Use.
    6. Magna Mitral Ease Instructions for Use.
    7. Medtronic Mosaic Bioprosthesis Aortic and Mitral Brochure. #UC200103933b EN.
    8. 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.
    9. 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.
    10. 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.
    11. 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

    EPICTM PLUS/ EPICTM 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.

    WARNINGS

    • Valve size selection is based on the size of the recipient annulus, and for supra-annular aortic placement, the anatomy of the sinotubular space. Implantation of an inappropriately large bioprosthesis may result in stent deformation, valvular incompetence, valve damage, diminished tissue durability and/or damage to the surrounding tissues. The use of an inappropriately small bioprosthesis may result in suboptimal hemodynamics. Use only the E2000 Epic™ Plus Heart Valve Sizer Set with the Epic™ Plus and Epic™ Plus Supra valves.
    • Accelerated deterioration due to calcific degeneration of the Epic Plus and Epic Plus Supra valve may occur in:
      • children, adolescents, or young adults;
      • patients with altered calcium metabolism (e.g., patients with hyperparathyroidism or chronic renal failure); or
      • individuals requiring hemodialysis.
    • For single use only. Do not reuse or resterilize. Attempts to resterilize the valve may result in valve malfunction, inadequate sterilization, or patient harm.
    • Passage of a catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not recommended.
    • Do not use if:
      • the valve has been dropped, damaged, or mishandled in any way, or if there is any sign of deterioration;
      • the expiration date has elapsed;
      • the tamper-evident container seal is damaged, broken, or missing, or if fluid is leaking from the packaging; or
      • the storage solution does not completely cover the valve.

    PRECAUTIONS

    • The safety and effectiveness of the Epic™ Plus and Epic™ Plus Supra valves has not been established for the following specific populations:
      • patients who are pregnant
      • nursing mothers
      • patients with chronic renal failure
      • patients with aneurysmal aortic degenerative conditions (e.g., cystic medial necrosis, Marfan’s syndrome)
      • patients with chronic endocarditis
      • patients requiring pulmonic or tricuspid valve replacement
      • children, adolescents, or young adults
    • Sizers are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, deformed, or damaged sizer set components.
    • Do not pass the flanged portion of the valve replica sizing tool through the annulus.
    • Do not place the non-sterile exterior of the valve container in the sterile field.
    • Do not expose the valve to solutions other than the formaldehyde valve storage solution in which it was shipped, the sterile isotonic saline solution used during the rinsing procedure, or the sterile isotonic saline solution used to irrigate the valve.
    • Do not add antibiotics to either the formaldehyde valve storage solution or the rinse solution.
    • Do not apply antibiotics to the valve.
    • Do not allow the valve tissue to dry. Place the valve in sterile isotonic saline rinse solution immediately upon removal from the valve storage solution. Once removed from this solution, the valve should be periodically irrigated during implantation.
    • Do not use the valve if shipping temperature indicators on the product carton have turned red, or if the valve has been improperly stored in temperature conditions outside of the 5 °C to 25 °C range.
    • Do not implant the valve without thoroughly rinsing as directed.
    • Do not lacerate the valve tissue. If a valve is damaged, the valve must be explanted and replaced.
    • Do not attempt to repair a valve. Damaged valves must not be used.
    • Do not use cutting edge needles, unprotected forceps, or sharp instruments as they may cause structural damage to valve.
    • Never handle the leaflet tissue.
    • Position the mitral valve in a manner to avoid commissure obstruction of the left ventricular outflow tract, and minimize any potential of commissure contact with the ventricular wall.
    • Position the aortic valve so that the stent posts do not obstruct the coronary ostia or come in direct contact with the aortic wall.
    • When implanting the Epic™ Plus heart valve, assess the suitability of the selected valve size and stent post position for a potential future valve-in-valve procedure and whether the transcatheter valve-in-valve procedure may result in left ventricular outflow tract or coronary ostia obstruction. For future valve-in-valve procedure in an Epic Plus valve, refer to the instructions for use supplied with the transcatheter heart valve along with reference dimensions in Table 1 (in the IFU) to determine compatibility. The safety and effectiveness of valve-in-valve procedures in an Epic™ Plus or an Epic™ Plus Supra valve have not been established.
    • Avoid prolonged contact with the formaldehyde storage solution. Immediately after contact, thoroughly flush any skin exposed to the solution with water. In case of contact with eyes, flush with water and seek appropriate medical care.

    ADVERSE EVENTS

    The clinical investigation of the Epic valve supports the safety and effectiveness of the Epic™ Plus valve and the Epic™ Plus Supra valve. Between January 2003 and March 2006, seven-hundred and sixty-two (762) subjects were implanted with 791 Epic Valve(s) at 19 investigational sites in the United States (U.S.), and three sites in Canada. Five-hundred and fifty-seven (557) subjects received isolated aortic replacement, 176 received isolated mitral replacement, and 29 received replacement of both the aortic and mitral valves. The cumulative follow-up for all subjects was 773.51 patient-years with a mean follow-up of 1.02 patient-years (s.d. = 0.71 patient-years, range 0 – 3.10 patient-years).

    Potential Adverse Events

    Adverse events potentially associated with the use of bioprosthesis 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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