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MITRIS RESILIA mitral valve

mitris and propeller
mitris and propeller
mitris and propeller

Designed to handle the pressure of the mitral position

As your trusted partner in cardiac surgery innovation, Edwards Lifesciences has developed the MITRIS RESILIA mitral valve to help meet the specialized needs of your patients.

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When replacement is the best choice, what if you had an option designed to be similar to the native valve?

old couple
old couple
old couple

Created for it

Developed with your patient's quality of life in mind

mitris resilia
mitris resilia
mitris resilia

Looks like it

A saddle-shaped sewing cuff mimics the native mitral annulus

mitris propeller
mitris propeller
mitris propeller

Performs like it

Handles the pressure of the mitral position

Key features of the MITRIS valve

perimount valve
perimount valve
perimount valve

Built on the Carpentier-Edwards PERIMOUNT valve platform

a platform with over 20 years of published clinical durability.1 

flourescence
flourescence
flourescence

Cobalt chromium bands provide good visibility under fluoroscopy

for easy identification of the landing zone for potential future transcatheter interventions.

dry storage
dry storage
dry storage

Dry storage

to eliminate need for rinsing.

low profile stents
low profile stents
low profile stents

Lowest profile stents

do not obstruct blood flow through the left ventricular outflow tract (LVOT).

^On a label size 25 mm. Anterior Profile Height.

An enhanced delivery experience

Mitris infographic
Mitris infographic
Mitris infographic

Need more information?

Download the brochure

RESILIA tissue clinical data:

Backed by a strong and growing body of clinical evidence supporting RESILIA tissue’s ongoing study of durability and hemodynamic performance 2, 3, 4

98.7%
98.7%
98.7%

COMMENCE mitral clinical trial

Clinically stable hemodynamics and one incident of structural valve deterioration (SVD) through 4 years in 82 patients.

gradient charts
gradient charts
gradient charts

Stable gradients Mean gradient (mmHg)

aortic commence stat
aortic commence stat
aortic commence stat

COMMENCE aortic clinical trial

Clinically stable hemodynamics and zero SVD through 5 years in 689 patients*.

*1 SVD diagnosed at post-operative day 1848

aortic graph
aortic graph
aortic graph

Stable gradients Mean gradient (mmHg)

European Aortic feasibility
European Aortic feasibility
European Aortic feasibility

European Aortic Feasibility trial

Clinically stable hemodynamics and zero SVD through 5 years in 133 patients.

European aortic
European aortic
European aortic

Mean gradient (mmHg) Valve sizes 19-27 mm

Promising data. Inspiring results.

RESILIA tissue story
Life R Icon
Life R Icon
Life R Icon

A promise of freedom.

That's the power of RESILIA tissue.

Learn more
lady earphones
lady earphones
lady earphones
lady earphones
lady earphones
lady earphones

MITRIS RESILIA mitral valve surgical technique video

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Device preparation animation

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MITRIS RESILIA mitral valve

The MITRIS RESILIA valve is designed to handle the pressure of the mitral position.

Built on the trusted Carpentier-Edwards PERIMOUNT valve platform, and made with RESILIA tissue for decreased calcification†, this is the mitral valve developed with your patient's quality of life in mind.

† No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.

mitris propeller
mitris propeller
mitris propeller

Indications for use

The MITRIS RESILIA mitral valve, Model 11400M is indicated for the replacement of native or prosthetic mitral heart valves.

Key materials list

  • Valve leaflets: Bovine pericardium
  • Stent: Cobalt-chromium alloy and polyester band with a nitinol wireform
  • Fabric stent covering: Polyester and Polytetrafluoroethylene (PTFE) cloth
  • Valve sewing ring: Silicone rubber

Tissue platform

The MITRIS valve features RESILIA tissue and is treated with a special integrity preservation technology that effectively eliminates free aldehydes while protecting and preserving tissue.

No clinical data are available that evaluate the long term impact of RESILIA tissue in patients.

General product information

  • Storage temperature: 10°C to 25°C
  • Storage: Dry storage
  • Rinse procedure: None required

The Edwards Advantage

We are committed to providing your institution, clinicians and staff with the highest levels of customer service and support to ensure seamless product implementation and ongoing use, including:

24/7 Technical support

800.822.9837

For product information and orders

800.424.3278
Mitral Replacement Valves
Mitral Replacement Valves
Mitral Replacement Valves

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References

  1. Bourguignon T, Bouquiaux-Stablo A, Loardi C, et al. Very long-term outcomes for mitral valve replacement with the Carpentier-Edwards pericardial bioprosthesis: 25-year follow-up of 450 implantations. J Cardiothorac Surg. 2014:148(5):2004-11. 
  2. Bartus K, Litwinowicz R, Bilewska A, et al. Final 5-year outcomes following aortic valve replacement with a RESILIA tissue bioprosthesis. Eur J Cardiothorac Surg. 2021;59(2):434-41. 
  3. Beaver T, Bavaria JE, Griffith B, et al. Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis. Presented at the 103rd Annual Meeting of the American Association for Thoracic Surgery, May 2023. 
  4. Heimansohn DA, Baker C, Rodriguez E, et al. Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissue. Ann Thorac Surg. 2023;115(6):1429-1436. 
Important safety information

Important safety information

MITRIS RESILIA Mitral Valve

Indications: For use in replacement of native or prosthetic mitral heart valves.

Contraindications: There are no known contraindications with the use of the MITRIS RESILIA mitral valve.

Complications and Side Effects: Thromboembolism, valve thrombosis, hemorrhage, hemolysis, regurgitation, endocarditis, structural valve deterioration, nonstructural dysfunction, stenosis, arrhythmia, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, ventricular perforation by stent posts, any of which could lead to reoperation, explantation, permanent disability, and death.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information.