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MITRIS RESILIA mitral valve

Clinical evidence

mitris and propeller
mitris and propeller
mitris and propeller

RESILIA tissue clinical data:

Backed by a strong and growing body of clinical evidence supported by RESILIA* tissue’s ongoing study of durability and hemodynamic performance1–3

98.7%
98.7%
98.7%

COMMENCE mitral clinical trial1

Clinically stable hemodynamics and one incident of structural valve deterioration (SVD) through 5 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 trial2

Clinically stable hemodynamics and two incidents of SVD through 7 years.

aortic graph
aortic graph
aortic graph

Stable gradients Mean gradient (mmHg)

European Aortic feasibility
European Aortic feasibility
European Aortic feasibility

European Aortic Feasibility trial3

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

Comparative study of the MITRIS RESILIA valve vs other commercially available porcine valves

Post-operative outcomes varied among the three mitral bioprostheses:†

  • The MITRIS RESILIA valve's larger surgical valve area likely led to lower peak and mean mitral gradients compared to other valves. It is likely that for the 27-mm Mosaic valve, the asymmetry, ventricular dimensions and smaller surgical area of the valve may have led to greater turbulent flow and higher mitral gradients than the MITRIS RESILIA valve4
Peak and mean gradients graph
Peak and mean gradients graph
Peak and mean gradients graph
Surgical valve area graph
Surgical valve area graph
Surgical valve area graph

Adapted from Wang DD, et al. J Card Surg. 2021.4

  • The strut protrusion into the left ventricle of the
    MITRIS RESILIA valve was lower than the Mosaic valve
    but comparable to the Epic valve4
  • Three of the four Epic mitral valves were reported to
    have paravalvular leak at the anterolateral
    commissure of the prosthesis sewing cuff. All other
    tissue valves had no paravalvular leaks4
Strut protrustion graph
Strut protrustion graph
Strut protrustion graph

Adapted from Wang DD, et al. J Card Surg. 2021.4

†Preclinical early feasibility experimental study evaluating three mitral bioprostheses (27 mm Epic valve, Abbott [n=4], 27 mm Mosaic valve, Medtronic [n=4], and 25 mm MITRIS RESILIA valve, Edwards Lifesciences [n=4]) under controlled, stable, haemodynamic and surgical conditions. Yorkshire pigs underwent implantation via thoracotomy on cardiopulmonary bypass. Epicardial echocardiographic studies were performed to assess haemodynamic function and define paravalvular leak, followed by contrast computerised tomography.

Full study summary
Full study summary
Full study summary
Download the brochure
Inspiring results
Inspiring results
Inspiring results
View the RESILIA tissue story
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Helpful resources

Visit the resources section for additional information on the MITRIS RESILIA valve.

References

  1. Heimansohn DA, et al. JTCVS Open. 2023;15:151–163.
  2. Beaver T, et al. J Thorac Cardiovasc Surg. 2023:S0022-5223(23)00873-5.
  3. Bartus K, et al. Eur J Cardiothorac Surg. 2021;59:434–41.
  4. Wang DD, et al. J Card Surg. 2021;36(12):4654–62.

*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

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).