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SURGICAL VALVE SOLUTIONS

EPIC™ MAX
AORTIC STENTED TISSUE VALVE CLINICAL DATA

The Abbott Epic valve platform has a decades-long history of safety and strong clinical outcomes. Epic Max has an optimized design to further improve valve blood flow.

BUILT ON THE EPIC™ PLATFORM THAT HAS STOOD THE TEST OF TIME

AT 10-YEARS

Over 11,000 Patients

94.6%

Freedom From All-Cause
Reintervention2

Over 1,900 Patients

96.3%

Freedom from SVD
(Structural Valve Degeneration)
All patient age3

DOWNLOAD THE EPIC MAX CORE BROCHURE

COMMITMENT TO VALVE-IN-VALVE* FOLLOW-UP DATA

3-YEAR OUTCOMES OF VALVE-IN-VALVE INTERVENTION

>95.0%

Epic™ Supra Valve
Patients Experienced Freedom from Valve
Intervention4

OPTIMIZE OUTCOMES WITH EXCELLENT HEMODYNAMICS

ESTIMATED EPIC™ MAX MEAN PRESSURE GRADIENTS AT 1 YEAR (MMHG)1

MEAN PRESSURE GRADIENT PREDICTED BASED ON MATCHED STENT ID FOR BIOCOR/EPIC™ VALVES.

Maximizing the internal orifice provides large effective orifice areas (EOAs) and low gradients to reduce the burden on the heart and contribute to better patient outcomes.

The safety and effectiveness of valve-in-valve procedures in an Epic™ Max valve has not been established

DOWNLOAD THE EPIC
MAX CORE BROCHURE

Download now

MAT-2307973 v1.0 | Item approved for U.S. use only.

References
  1. [a] Biocor IFU [b] Maitland, Andrew, Gregory M. Hirsch, and Edward A. Pascoe. “Hemodynamic Performance of the St. Jude Medical Epic™ Supra Aortic Stented Valve.” Journal of
    Heart Valve disease 20.3 (2011): 327. [c] Epic Plus IFU
  2. Wiechmann, RJ., et. al. Ten-year Outcomes of Surgical Aortic Valve Replacement with a Contemporary Supra Annular Porcine Valve in a Medicare Population. JTCVS Open. 2022, doi.org/10.1016/j.xjon.2022.08.002.
  3. 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.
  4. H. Kenith Fang, et al. Three-Year Outcomes of Valve-in-Valve Intervention within the Epic™ Supra and Epic™ Mitral Valves in a Medicare Population. TVT Conference 2022; Chicago, USA; June 9th, 2022.
Important Safety Information

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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