EpicTM Mitral

Exceptional Durability
Compared to Other
SAVR Mitral Valves

Durability that Withstands the Long-Term Test of Time

The EpicTM stented tissue valve with LinxTM anticalcification (AC) technology has impressive 10-year durability data. And it stands on the legacy of the 20 years of published durability data and 25 years of clinical experience from the BiocorTM valve.*

*Based on available 10+ and 20+ year retrospective studies.

Freedom from Structural Valve Deterioration1




EpicTM Valve at 10 Years

EpicTM Valve at 10 Years

EpicTM Mitral Valve Carries on the Long-Term Success of BiocorTM

When evaluating longer term data from the EpicTM valve’s predecessor, the BiocorTM valve,2 its durability—at all patient ages—is impressive compared to the competing PERIMOUNTTM valve3 and the HancockTM II valve.4,†

ACTUARIAL Freedom from Reoperation due to Structural Valve Deterioration AT 15 YEARS2-4

Results from different clinical trials are not directly comparable. Information provided for educational purposes only. 
‡ Interpolated from Borger data, Figure 5.

  • Robust Evidence on Long-Term Outcomes
    Pia Mykén, et al.2

    The 20-year data “provides some of the most robust evidence available on long-term outcomes after bioprosthetic heart valve replacement. Long-term durability is the most important parameter when evaluating bioprosthesis, and these results clearly demonstrate the excellent durability of the Biocor bioprosthesis over 20 years.”
     

Exceptional Outcomes with Adverse Events

In addition to its durability, the EpicTM Mitral valve exhibits impressive rates of freedom from adverse event.
 

§ From mitral valve replacement, not double valve replacement

AP2947048-WBU Rev. A

References
  1. Lehmann S, Jawad K, Meyer A, et al. Long-term follow-up after porcine xenograft mitral valve replacement. Presented at: American Association for Thoracic Surgery Mitral Conclave; April 27-28, 2017; New York, NY USA.
  2. Mykén PS,  Bech-Hansen O. A 20-year experience of 1712 patients with the Biocor porcine bioprosthesis. J Thorac Cardiovasc Surg. 2009;137:76-81. 
  3. Bourguignon T, Bouquiaux-Stablo AL, Loardi C, et al. Very late outcomes for mitral valve replacement with the Carpentier-Edwards pericardial bioprosthesis: 25-year follow-up of 450 implantations. J Thorac Cardiovasc Surg. 2014;148:2004-2011. 
  4. Borger MA, Ivanov J, Armstrong S, et al. Twenty-year results of the Hancock II bioprosthesis. J Heart Valve Dis. 2006;15:49-56.
  5. Lehmann S, et al. Mid-term results after Epic™ xenograft implantation for aortic, mitral, and double valve replacement. J Heart Valve Dis. 2007;16:641-648.
     
Important safety information

EPICTM/ EPICTM SUPRA STENTED PORCINE TISSUE VALVES
INDICATION FOR USE


The EpicTM 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 EpicTM 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, and/or damage to the surrounding tissues. The use of an inappropriately small bioprosthesis may result in suboptimal hemodynamics. Use only the St. Jude MedicalTM Bioprosthetic Heart Valve Sizer Set Model B1000 with the Epic and Epic Supra valves.
  • Accelerated deterioration due to calcific degeneration of the Epic and Epic 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 EpicTM and EpicTM 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.
  • 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 valve and the Epic 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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