MITRIS RESILIA mitral valve

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.

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

Created for it

Developed with your patient's quality of life in mind

Looks like it

A saddle-shaped sewing cuff mimics the native mitral annulus

Performs like it

Handles the pressure of the mitral position

Picture of Mitris valve and propeller plane

Key features of the MITRIS valve

Built on the Carpentier-Edwards PERIMOUNT valve platform

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

Picture of Mitris desmonstrating good visibility

Cobalt chromium bands provide good visibility under fluoroscopy

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

Dry storage

to eliminate need for rinsing.

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

A Posteromedial commissure mark (single black line), an anterolateral commissure mark (double black line), and an anterior segment mark (“A” mark). The black suture markers facilitate the orientation of the valve and help avoid obstruction of the left ventricular outflow tract by stent posts.

Nitinol stents fold down to 55 degrees, allowing for ease of implant; stents return to original position when valve is implanted.

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, 5}

COMMENCE Mitral clinical trial

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

98.7% Actuarial freedom from SVD
through 4 years

Stable gradients Mean gradient (mmHg)

graph showing commence clinical trial mitral through 4 years

COMMENCE Aortic clinical trial

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

100% Actuarial freedom from SVD
through 5 years^*

*1 SVD diagnosed at post-operative day 1848

Stable gradients Mean gradient (mmHg)

graph showing commence clinical trial aortic through 5 years

European Aortic Feasibility trial

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

100% Actuarial freedom from SVD
through 5 years

Mean gradient (mmHg) Valve sizes 19-27 mm

graph showing European feasability trial through 5 years

Promising data. Inspiring results.

RESILIA tissue story

Device preparation animation

References

Bourguignon T, 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.
Flameng W, et al. A radomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardivasc Surg. 2015:149:340-5.
Bartus K, et al. Final 5-year outcomes following aortic valve replacement with a RESILIA tissue bioprosthesis. Eur J Cardiothorac Surg. 2021:59(2):434-41.
Bavaria J, et al. Five-year outcomes of the COMMENCE trial investigating aortic valve replacement with a novel tissue bioprosthesis. Society of Thoracic Surgery, 2021 Annual Meeting
Heimansohn D, et al. Mitral Valve Replacement using a Pericardial Valve with RESILIA Tissue. American Association of Thoracic Surgery, 2021 Annual Meeting.

Specifications

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 mitigates 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

Models

Model	Description	Sizes	Images
11400M	MITRIS RESILIA mitral valve	25, 27, 29, 31, 33 mm

Accessories

Model	Description	Sizes
1140M	Reusable Handle	N/A

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: