CARDIOVASCULAR
hamburger
product photo

EPIC. BY DESIGN.

The Epic stented tissue valve with Linx™ anticalcification (AC) technology is engineered to deliver excellent durability and performance, as well as smooth, streamlined implantability.

With the lowest overall ventricular protrusion in all valve sizes,1-5 the Epic Mitral valve is an excellent choice for the mitral position. With its low profile, the Epic heart valve can:

  • Reduce the risk of left ventricular outflow tract obstruction6
  • Avoid requiring a specific orientation during implantation
  • Allow for easy implantability during minimally invasive surgery (MIS)

The Epic Mitral valve is based on the same design as the Biocor™ valve, a bioprosthetic heart valve that is supported by 20 years of published durability data and 25 years of clinical experience.

LINX AC TECHNOLOGY

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

  • Extracting lipids7
  • Reducing free aldehydes8,9
  • Minimizing cholesterol uptake10
  • Stabilizing leaflet collagen10

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

EPIC MITRAL VALVE DURABILITY AND ENHANCED CONTROL

The Epic Mitral valve’s triple composite design and unique pericardial shield are designed for durability. To facilitate the implant procedure, the Epic valve also features the FlexFit™ system, comprised of:

  • A flexible polymer stent
  • Ratcheting holder
  • Rinse time of 2 x 10 seconds

 

 

References

1. Epic valve [package insert]. Chicago, IL: Abbott; table 1.
2. Carpentier-Edwards PERIMOUNT THEON™ Mitral Replacement System Brochure. #AR00856. 
3. Edwards PERIMOUNT Magna™ Mitral Pericardial Bioprosthesis Brochure. #AR01603. 
4. Medtronic Mosaic™ Bioprosthesis Aortic and Mitral Brochure. #UC200103933b EN. 
5. Medtronic Hancock II™ and Hancock II Ultra™ Bioprosthesis Brochure.
6. 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;33:399-401.
7. 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.
8. 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. 
9. 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. Austin: Silent Partners, Inc; 1997:105-113.
10. 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.

DESIGNED TO BE VERSATILE AND MADE TO BE ADAPTABLE

The Epic Mitral valve achieves minimal valvular regurgitation by providing two features crucial in the mitral position: impressive paravalvular cuff sealing and central leaflet coaptation.

The valve’s innovative triple composite design uses 3 separate porcine leaflets to optimize leaflet coaptation, reduce stress, and mitigate regurgitation. The conformable sewing cuff further minimizes regurgitation in high-risk anatomies, such as calcified mitral annulus.

THE INNOVATIVE FLEXFIT™ SYSTEM

Epic heart valve features

 

References

1. Epic valve [package insert]. Chicago, IL: Abbott; table 1.
2. Carpentier-Edwards PERIMOUNT THEON™ Mitral Replacement System Brochure. #AR00856. 
3. Edwards PERIMOUNT Magna™ Mitral Pericardial Bioprosthesis Brochure. #AR01603. 
4. Medtronic Mosaic™ Bioprosthesis Aortic and Mitral Brochure. #UC200103933b EN. 
5. Medtronic Hancock II™ and Hancock II Ultra™ Bioprosthesis Brochure.
6. 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;33:399-401.

EXCEPTIONAL DURABILITY COMPARED TO OTHER SURGICAL MITRAL VALVES

Durability is a critical factor to consider with bioprosthetic heart valves, and the Epic Mitral valve has an impressive long-term track record of 10-year durability.


Freedom from Structural Valve Deterioration7

Epic Mitral Valve outperforms other valves


Freedom from Reoperation due to Structural Valve Deterioration

Epic Mitral Valve outperforms other valves

When evaluating data from the Epic valve’s predecessor, the Biocor valve,8 its durability is impressive compared to competitors the Perimount™ valve9 and the Hancock™ II valve.10,*


*Results from different clinical trials are not directly comparable. Information provided for educational purposes only.

 

References

1. Epic valve [package insert]. Chicago, IL: Abbott; table 1.
2. Carpentier-Edwards PERIMOUNT THEON™ Mitral Replacement System Brochure. #AR00856.
3. Edwards PERIMOUNT Magna™ Mitral Pericardial Bioprosthesis Brochure. #AR01603.
4. Medtronic Mosaic™ Bioprosthesis Aortic and Mitral Brochure. #UC200103933b EN.
5. Medtronic Hancock II™ and Hancock II Ultra™ Bioprosthesis Brochure.
6. 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;33:399-401
7. 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.
8. 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.
9. 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.
10. Borger MA, Ivanov J, Armstrong S, et al. Twenty-year results of the Hancock II bioprosthesis. J Heart Valve Dis. 2006;15:49-56.

EPIC MITRAL VALVE ORDERING INFORMATION

Model Number

Valve Size (mm)

Tissue Annulus Diameter (mm)

Internal Diameter (Stent ID mm)

Ventricular Protrusion (mm)

Total Height (mm)

E100-25M-00

25

25

23

9

16

E100-27M-00

27

27

25

9

17

E100-29M-00

29

29

27

10

19

E100-31M-00

31

31

29

10

20

E100-33M-00

33

33

31

11

20

 

References

1. Epic valve [package insert]. Chicago, IL: Abbott; table 1.
2. Carpentier-Edwards PERIMOUNT THEON™ Mitral Replacement System Brochure. #AR00856. 
3. Edwards PERIMOUNT Magna™ Mitral Pericardial Bioprosthesis Brochure. #AR01603. 
4. Medtronic Mosaic™ Bioprosthesis Aortic and Mitral Brochure. #UC200103933b EN. 
5. Medtronic Hancock II™ and Hancock II Ultra™ Bioprosthesis Brochure.
6. 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;33:399-401.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

rx-only-logoEPIC™/ EPIC™ SUPRA STENTED PORCINE TISSUE VALVES

INDICATIONS FOR USE

The Epic™ 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™ Supra different 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 Medical™ 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 Epic™ and Epic™ 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

AP2946718-WBU Rev. A

You are about to exit the Abbott family of websites for a 3rd party website

Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott.


The website that you have requested also may not be optimized for your screen size.

Do you wish to continue and exit this website?

true
accessibility
© 2016 Abbott. All Rights Reserved. Please read the Legal Notice for further details.

Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

accessibility

You are about to exit the Abbott family of websites for a 3rd party website

Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott.


The website that you have requested also may not be optimized for your screen size.

Do you wish to continue and exit this website?