Mitris Resilia is a tissue valve replacement for the heart’s mitral position. It was developed by Edwards Lifesciences, a medical technology company based in the US.
The valve uses technology based on resilia – bovine pericardial tissue. It addresses the needs of patients suffering from mitral valve heart disease. The technology offers anti-calcification properties, minimises calcium buildup on the valve and preserves the tissue, potentially extending the lifespan of the valve compared to traditional bioprosthetic valves.
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In October 2023, Edwards received the CE [Conformité Européenne] mark for the valve for mitral replacement surgeries. It was approved by the US Food and Drug Administration (FDA) in March 2022. The valve is also approved by regulatory agencies in countries including Japan and Canada.
Mitris Resilia valve details
The Mitris Resilia valve comprises several key components, including valve leaflets, valve sewing ring and stent frame.
The valve leaflets are the movable components that open and close to regulate blood flow through the heart. The leaflet is made of bovine pericardium, a type of biological material derived from the pericardium, the sac surrounding the heart of a cow. The tissue is used in the manufacturing of bioprosthetic heart valves, due to its durability, biocompatibility and mechanical properties that closely mimic human heart tissue.
The stent features cobalt-chromium alloy and polyester band with a nitinol wireform, covered by polyester and polytetrafluoroethylene (PTFE) cloth. The stent frame provides structural support to the valve and helps maintain its shape and function within the heart.
The valve sewing ring is made of silicone rubber. It is integrated into the valve design, providing a stable platform for surgeons to securely attach the valve to the patient’s native tissue during implantation.
Mitris Resilia valve design and features
The Mitris Resilia valve, developed from the Edwards Lifesciences’ Carpentier-Edwards PERIMOUNT valve platform, is specifically engineered to withstand the demands of the mitral position. It features a saddle-shaped sewing cuff that emulates the asymmetrical shape of the native mitral valve, ensuring an optimal fit and enhanced performance and longevity.
The innovative design of the PERIMOUNT valve mitigates the risk of obstructing the left ventricular outflow tract (LVOT). It incorporates a nitinol wireform capable of inward folding up to 550 during implantation, facilitating a more efficient and less invasive surgical procedure.
Once the valve is in place, the stents reassume their original position. Additionally, the valve is equipped with black commissure markers to aid in the correct orientation, further ensuring the stent posts do not impede the LVOT.
A notable feature of the Mitris Resilia valve is its exceptional visibility under fluoroscopy, courtesy of the cobalt-chromium bands. This characteristic is particularly beneficial for delineating the landing zone during potential future transcatheter interventions, thereby offering a clear advantage for patient care.
The Mitris Resilia valve is available in 25mm, 27mm, 29mm, 31mm and 33mm sizes, as denoted by the 11400M model series. The size ranges ensure that the valve can accommodate a wide spectrum of patient anatomies, making it a versatile choice for mitral valve replacement.
Resilia tissue technology
The Resilia tissue technology not only preserves the valve but also allows increased durability. The special integrity preservation technology streamlines the surgical process effectively eliminating free aldehydes while protecting the tissue.
The advanced Resilia tissue with an anti-calcification technology offers the convenience of dry packaging, simplifying the storage at a temperature of 10°C to 25°C and facilitating ease of use by medical professionals.
Clinical trials on Mitris Resilia mitral valve
Resilia tissue was studied in COMMENCE clinical trials to evaluate its durability and haemodynamic performance. It comprises two robust pre-market clinical trials, the COMMENCE Mitral clinical trial and the COMMENCE Aortic clinical trial.
The data from the COMMENCE Aortic trial demonstrated remarkable freedom from structural valve deterioration (SVD) (99.3%), stability in pressure gradients and a high rate of freedom from reoperation (97.2%) over seven years. These statistics highlight the potential longevity of the Mitris Resilia mitral valve and its ability to maintain optimal functionality over an extended period.
The COMMENCE Mitral trial also reported favourable outcomes, with clinically stable haemodynamics and an impressive 98.7% freedom from SVD at five years in patients. The data underscored the reliability and durability of the valve in real-world clinical settings.
The outcomes reported by the European aortic clinical trial demonstrated 100% actuarial freedom, with clinically stable haemodynamics and zero SVD in 133 patients over five years.
