The MITRIS RESILIA valve
Specifically designed for the mitral position
It is also optimised for ease of use:
- An asymmetrical saddle-shaped sewing cuff that mimics the native mitral annulus, for an effective seating and seal
- Foldable, nitinol stent posts that minimise the potential occurrence of suture entrapment/looping
- Black "A" markings to ensure optimal orientation with the anterior portion of the mitral annulus
- A single-cut point for easy release
Adapted from the MITRIS RESILIA valve Instructions for use and Design requirements document.3,4
Additional beneficial design features of the MITRIS RESILIA valve include:
- Low-profile stents that do not obstruct blood flow through the left ventricular outflow tract (LVOT)
- An atrialised cuff design that tilts the posterior stent post away from the left ventricular (LV) wall, reducing ventricular protrusion and minimising risk of LV wall injury
- Cobalt chromium band and nitinol wireform stent to provide good visibility under fluoroscopy for easy identification of the landing zone for potential future transcatheter interventions
The MITRIS RESILIA valve's size may help minimise valve-related problems during replacement, however, it is important to note that there is a lack of standardisation with the labelled prosthesis sizing e.g. the 25 mm MITRIS RESILIA valve is the same size as the 27 mm porcine valves.5 Below are key design features that give the MITRIS RESILIA valve an advantage over porcine valves.3,5–7
Compared to Abbott EpicTM and Medtronic MosaicTM porcine valves, the MITRIS RESILIA valve has the widest strut opening at the anterior position†5
Due to the small sample size, only descriptive data is presented with no further statistical analysis.
Among all valve sizes, the MITRIS RESILIA valve offers the lowest anterior profile relative to Abbott EpicTM and Medtronic MosaicTM porcine valves†3,5–7
MITRIS RESILIA valve label size corresponds to stent diameter (except for the 33mm label size); porcine valves label size corresponds to OD-HOUSING.
How does the design of the MITRIS RESILIA valve impact haemodynamic performance?
*Clinical data on surgical aortic valves with RESILIA tissue up to 7-year follow-up have been published, with additional follow-up to 10 years in progress.10
†A head-to-head study evaluating three mitral bioprostheses of comparable measured internal diameters implanted in 12 Yorkshire pigs with similar-sized cardiac anatomy (27 mm Abbott EpicTM mitral valve [n=4]; 27 mm Medtronic MosaicTM mitral valve [n=4]; 25 mm MITRIS RESILIA valve [n=4]) via thoracotomy on cardiopulmonary bypass (CPB). After CPB, epicardial echocardiographic measurements were performed to assess haemodynamic function, followed by post-operative gated contrast computed tomography (CT). To ensure comparable anatomical and haemodynamic study conditions, pigs with a >6% anatomical variation were excluded from the study.5
Abbreviations
CPB, cardiopulmonary bypass; CT, computed tomography; LV, left ventricular; LVOT, left ventricular outflow tract.
References
- Ghanbari J, et al. Front. Mech. Eng. 2022;8:764034.
- Flameng W, et al. J Thorac Cardiovasc Surg. 2015;149:340–45.
- Edwards Lifesciences. MITRIS RESILIA mitral valve, model 11400M, Instructions for use. 2024.
- Edwards Lifesciences. MITRIS RESILIA mitral valve, model 11400M, Design requirements document.
- Wang DD, et al. J Card Surg. 2021;36(12):4654–62 & supplementary materials.
- Abbott. Epic Plus/Epic Plus Supra stented porcine tissue valves, Instructions for use. 2021.
- Medtronic Inc. Mosaic bioprosthesis, Instructions for use. 2018.
- Silbiger J, et al. Echocardiography. 2019;36(6):1165–72.
- Zhang HJ, et al. Asian Cardiovasc Thorac Ann. 2006;14(1)26–9.
- Beaver T, et al. J Thorac Cardiovasc Surg. 2024;168(3):781–91.
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).
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