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SURGICAL VALVE SOLUTIONS

EPIC™ PLUS MITRAL AND AORTIC STENTED TISSUE VALVES CLINICAL DATA

The latest generation of the Epic™ platform continues the Epic product family’s history of excellence. The future-forward design of the Epic Plus mitral and aortic valves gives you and your patients more choices when it comes to preserving long-term treatment paths.

DURABILITY THAT WITHSTANDS
THE LONG-TERM TEST OF TIME

At 10 Years

93.8%*

Freedom from SVD,
all patient ages (Epic™ Mitral VALVE)1

96.3%*

Freedom from SVD,
all patient ages (Epic™ Aortic VALVE)1

SVD: structural valve deterioration.
*From stand-alone aortic or mitral valve replacements.
 

THE EPIC PLATFORM HAS DEMONSTRATED EXCELLENT DURABILITY IN YOUNGER PATIENTS

The Epic™ Mitral valve experience from Rennes shows excellent performance in younger patients, with a 10-year freedom from SVD of 87.7% for the age ≤ 59 subgroup.2

 

87.7%

EPIC MITRAL VALVE
Freedom from SVD,
at 10 YEARS2

EPIC SUPRA VALVE DELIVERS EXCEPTIONAL DURABILITY AND PERFORMANCE

  • Optimal leaflet design minimizes regurgitation
  • Pericardial shield reduces abrasion by creating tissue-to-tissue interface
  • Epic valve 10-year durability data show outstanding aortic freedom from SVD1 

96.3%

EPIC AORTIC VALVE
Freedom from SVD,
at 10 YEARS1

STRONG FORWARD FLOW HEMODYNAMICS

Mean Pressure Gradients at 1 year (mmHg)

MAT-2115621 v3.0 | Item approved for U.S. use only.

References
  1. Lehmann, S, Merk DR, Etz CD, et al. Porcine xenograft for aortic, mitral and double valve replacement: long-term results of 2544 consecutive patients. Eur J Cardiothorac Surg. 2016;49:1150-1156.
  2. Anselmi A, Aymami M, Tomasi J et al. Durability of mitral valve replacement with a 3rd generation bioprosthesis. Ann Thorac Surg. 2021. doi: https://doi. org/10.1016/j.athoracsur.2021.03.097.
  3. Biocor Instructions for Use.
  4. Maitland A, Hirsch GA, and Pascoe EA. Hemodynamic performance of the St. Jude Medical Epic Supra Aortic Stented Valve. J Heart Valve Dis, 2011; 20:327-331.
Important Safety Information

Rx Only

EPIC™ PLUS/EPIC™ 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.

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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