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
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
Cobalt chromium bands provide good visibility under fluoroscopy
for easy identification of the landing zone for potential future transcatheter interventions.
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.
through 4 years
Stable gradients Mean gradient (mmHg)
COMMENCE Aortic clinical trial
Clinically stable hemodynamics and zero SVD through 5 years in 689 patients.
through 5 years*
*1 SVD diagnosed at post-operative day 1848
Stable gradients Mean gradient (mmHg)
European Aortic Feasibility trial
Clinically stable hemodynamics and zero SVD through 5 years in 133 patients.
through 5 years
Mean gradient (mmHg) Valve sizes 19-27 mm
Promising data. Inspiring results.RESILIA tissue story
- 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.
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
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
|11400M||MITRIS RESILIA mitral valve||25, 27, 29, 31, 33 mm|
|1173B||Barrel Sizers - Individual||25, 27, 29, 31, 33 mm|
|1173R||Replica Sizers - Individual||25, 27, 29, 31, 33 mm|
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 support800-822-9837
For product information and orders800-268-3993
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.
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