Trifecta™ Valve

This device is commercially available for use in the United States.

When the Goal Is Exceptional Hemodynamics the Valve Is Trifecta1

Introducing the next-generation pericardial tissue heart valve–and perfect complement–to the line of tissue valves from St. Jude Medical that includes Epic™ and Biocor™. The Trifecta valve is a stented tissue heart valve with exceptional in vivo mean gradients across all valve sizes.1 The unique valve design includes pericardial tissue leaflets attached to the exterior of the valve stent allowing it to open more fully and efficiently to perform like a natural heart valve.

1. St. Jude Medical. Trifecta Valve, Pre-Market Approval Application Summary of Safety and Effectiveness Data, P100029, 2011.

Trifecta Valve Instructions For Use

Designed for outstanding performance in all three areas of hemodynamics, durability and implantability, the Trifecta valve demonstrates our passion for putting more control into the hands of physicians.

Learn more about the Trifecta manufacturing process and quality measures.

When the Goal Is Hemodynamics

Created exclusively for the aortic position, the Trifecta valve delivers larger EOAs, resulting in single-digit pressure gradients.1 The Trifecta valve is designed to mimic the flow of a natural, healthy heart valve and offers excellent hemodynamic performance, which may provide patients with an improved quality of life.

 Mean Gradient Chart

In vivo single-digit mean gradients averaged across all valve sizes at six months.1

Effective Oriface

Large EOAs across all valve sizes result in decreased risk of patient-prosthesis mismatch at six months.1

 

When the Goal is Durability

With more than 30 years of market experience, the Trifecta valve was designed for long-term durability and performance. The result is a design that has demonstrated excellent in vitro wear testing.2

Trifecta Diagram

 

1. Pericardial covered stent for tissue-to-tissue contact reducing
    the risk of abrasion and structural valve deterioration.2

2. Elimination of tacking suture at top of commissure reduces risk
    of tearing.

3. Proper leaflet shaping and coaptation are achieved through 
    proprietary tissue leaflet fixation.2

4. Leaflets from a single pericardial sheet, externally mounted,
    optimize coaptation and maximize flow.

 

 

Trifecta Stent

 

 

 

 

Fatigue-resistant, high-strength titanium stent designed to reduce stress on leaflets during cardiac cycle.2

 

 

 

  

 

When the Goal is Implantability

The Trifecta valve offers superior hemodynamic performance1 with the implantability of a stented valve, accommodating a surgeon's existing implantation technique.

  • Contoured silicone insert within a unique polyester cuff is designed to conform to the shape of the native annulus for proper seating and to reduce the risk of PV leak.1
  • Trifecta valve sizers are optimized for true-to-size selection.
  • Efficient 2 x 10-second rinse.
  • Aortic valve holder improves visibility and cuff access for suturing.
  • Both the flexible and rigid valve holder handles provide quick, click-in handle attachment and removal to stabilize the valve and minimize the risk of unseating.

 

1. St. Jude Medical. Trifecta Valve, Pre-Market Approval Application Summary of Safety and Effectiveness Data, P100029, 2011.

2. Data on File, St. Jude Medical.

Trifecta Valve

Reference Dimensions and Ordering Information

Model/Reorder Number Tissue Annulus Diameter (mm) Cuff Outer Diameter (mm) Total Height (mm)  Aortic Protrusion (mm)
TF-19A 19 24 15 12
TF-21A 21 26 16 13
TF-23A 23 28 17 13
TF-25A 25 31 18 14
TF-27A 27 33 19 15
TF-29A 29 35 20 16

Trifecta Valve Implant Procedure

Implant Procedure Thumbnail

The Trifecta valve has been specifically designed for excellent hemodynamic performance, durability and implantability. Watch this implant procedure to understand how the Trifecta valve is redefining the standard in cardiac surgery for tissue valves.

 

 

 

How to properly size the Trifecta valve

Sizing Animation Thumbnail

The Trifecta valve is designed for supra-annular placement. Valve size selection is based on the size of the annulus and the anatomy of the sinotubular junction. Watch this animation to understand how to properly size the Trifecta valve. 

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