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MITRIS RESILIA mitral valve

Features

mitris and propeller
mitris and propeller
mitris and propeller

MITRIS RESILIA:* designed to handle the pressure of the mitral position

Mitral regurgitation is one of the most common valvular heart diseases, predominantly affecting patients ≥65 years of age.1-3  If left untreated, moderate-severe mitral regurgitation is associated with excess morbidity and mortality.4

In addition, the median age for mitral valve replacement patients is relatively young, at 66 years.5 Combined with an increasing life expectancy,6 it is more important than ever that there’s a tissue valve built to last for patients in the long-term.

Edwards Lifesciences brings you the MITRIS RESILIA valve, designed to handle 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

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 anterior profile stents

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

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

Device preparation animation


Incorporating RESILIA tissue technology

RESILIA tissue is bovine pericardial tissue treated with a special integrity preservation technology that mitigates free aldehydes, a key factor in tissue calcification.7 The tissue is also stored dry to prevent further glutaraldehyde exposure.

Incorporating RESILIA tissue
Incorporating RESILIA tissue
Incorporating RESILIA tissue

The MITRIS RESILIA valve is designed to offer enhanced tissue anticalcification technology that will potentially allow the valve to last longer

RESILIA tissue demonstrates significantly less calcium compared to other bovine tissues, offering the possibility of delaying potential surgical re-interventions later in life.9

An enhanced delivery experience

Mitris infographic
Mitris infographic
Mitris infographic

Indications for use8

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. Additional clinical data for up to 10 years of follow-up are being collected to monitor the long-term safety and performance of RESILIA tissue.

General product information

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

References

  1. Singh JP, et al. Am J Cardiol. 1999;83(6):897–902. 
  2. Nkomo VT, et al. Lancet. 2006;368(9540):1005–11. 
  3. De Backer OD, et al. Circ Cardiovasc Interv. 2014;7(3):400–9. 
  4. Dziadzko V, et al. Lancet. 2018;391(10124):960–9. 
  5. Romano M, et al. J Thorac Cardiovasc Surg. 2023:S0022–5223(23)00968-6. 
  6. World Health Organisation. GHE: Life expectancy and healthy life expectancy. Available at: https://www.who.int/data/gho/data/themes/mortality-and-global-health-estimates/ghe-life-expectancy-and-healthy-life-expectancy. Accessed June 2024.
  7. Flameng W, et al. J Thorac Cardiovasc Surg. 2015;149:340–45.  
  8. Edwards Lifesciences. MITRIS RESILIA Mitral Valve, Model 11400M, Instructions for use.
  9. Heimansohn DA, et al. JTCVS Open. 2023;15:151–163.

*No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients. Additional clinical data for up to 10 years of follow-up are being collected to monitor the long-term safety and performance of RESILIA tissue.

Medical device for professional use

For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).