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SURGICAL VALVE SOLUTIONS

EPIC™ MAX
AORTIC STENTED TISSUE VALVE CLINICAL DATA

Our latest aortic valve replacement solution for optimizing key clinical outcomes and the possibilities for patient lifetime management.

SURGICAL VALVE SOLUTIONS

EPIC™ MAX
AORTIC STENTED TISSUE VALVE CLINICAL DATA

Our latest aortic valve replacement solution for optimizing key clinical outcomes and the possibilities for patient lifetime management.

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

AT 10-YEARS

Over 11,000 Patients

94.6%

Epic Supra Valve

Freedom From All-Cause
Reintervention2

Over 1,900 Patients

96.3%

Epic Supra Valve

Freedom from SVD
(Structural Valve Degeneration)
All patient age3

DOWNLOAD THE EPIC MAX BROCHURE

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

3-YEAR OUTCOMES OF VALVE-IN-VALVE INTERVENTION IN A U.S. POPULATION

>95.0%

Epic™ Supra Valve
Patients Experienced Freedom from Valve
Intervention4

OPTIMIZE OUTCOMES WITH EXCELLENT HEMODYNAMICS

ESTIMATED MEAN PRESSURE GRADIENT AT 1 YEAR FOR EPIC MAX (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 BROCHURE

Download now

MAT-2307973 v2.0 | 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. Lehmann S, Merk DR, Etz CD, Oberbach A, Uhlemann M, Emrich F et al. Porcine xenograft for aortic, mitral and double valve replacement: long-term results of 2544 consecutive patients. Eur J Cardiothorac Surg 2016;49:1150–6.
  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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