Big ideas with the power for change are the cornerstone on which Edwards Lifesciences was founded. So when we ask ourselves, is it possible? The answer must be yes. Because improving the quality of life for structural heart patients around the world has always been our mission.
Learn how Edwards Lifesciences is enabling better quality of care for patients through structural heart disease awareness and aortic heart valve replacement approaches.
initiative aims to improve the outcomes of patients living with aortic stenosis. Learn more
Not just for older patients anymore
The latest guidelines recommend tissue valves for patients as young as 50 years old.
2014 AHA/ACC guidelines were updated in 2017 to expand the age consideration of either a tissue or a mechanical valve from 60-70 years of age to now include younger patients between 50-70 years of age.
2017 AHA/ACC guidelines of valve type by patient age
Tissue and mechanical valve comparison summary
|Tissue valves||Mechanical valves|
|Long-term blood thinner required||No||Yes Daily blood thinner medication and regular blood tests for rest of life|
|Valve longevity||10 to over 20 years, depending on type of valve, patient characteristics, and other factors RESILIA tissue has been shown in animal studies to have less calcium build-up, potentially allowing the valve to last longer.1*||Over 20 years, in general|
|Lifestyle and dietary considerations||Yes May need to reduce calcium intake||Yes Limits active lifestyle and foods high in vitamin K (such as leafy greens) from diet|
|Noticeable sounds from valve||No||Yes Clicking sound as valve opens and closes|
|Pregnancy considerations||No No known pregnancy complication risk||Yes High pregnancy complication risks due to use of blood thinners|
1*RESILIA tissue has not been studied for long term results in patients.
The right choice today.
Because today, your patients want an improved quality of life and the potential to expand their future options.
Built with RESILIA tissue†, the INSPIRIS RESILIA aortic valve is designed to oﬀer enhanced tissue anti-calciﬁcation technology that will potentially allow the valve to last longer.1
The INSPIRIS RESILIA valve delivers on the promise of better ongoing patient quality of life without the inconvenience of monitoring, dietary restrictions and reduction of participation in active lifestyles typically seen with a mechanical valve.2,3
The INSPIRIS valve possesses many advantages over a mechanical valve:
- Freedom to live a more active lifestyle
- Fewer dietary restrictions
- No need for long-term anticoagulants
- No clicking sound with every heartbeat
†No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.
Ready for tomorrow.
Help your patients meet the future confidently, with enhanced options for subsequent valve intervention.
The INSPIRIS aortic valve incorporates novel VFit technology, designed to enable valve-in-valve procedures in the future, at a time when patients are older and potentially at a higher risk for complications.
Proven performance for your patientsBacked by a strong and growing base of preclinical and clinical evidence supporting its ongoing study of durability and hemodynamic performance.1, 4, 5
Expanding future possibilities for you and your patients starts today.
“Patients undergoing a valve replacement are living long lives and remaining more active through their later years, increasing the need for advanced valve replacement technologies. The absence of structural valve deterioration in these patients is extremely encouraging and highlights the potential of valves containing RESILIA tissue for patients who may otherwise opt for a mechanical valve, which requires long-term use of blood thinning medications.”John D. Puskas, MD Principal investigator for the COMMENCE study
COMMENCE Trial Clinical Summary
The COMMENCE trial: Four-year outcomes with an aortic bioprosthesis with RESILIA tissue.Download brochure
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- FlamengW, et al. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J ThoracCardiovasc Surg. 2015; 149:340–5.
- Ruel M, et al. Long-term outcomes of valve replacement with modern prostheses in young adults. Eur J Cardiothorac Surg. 2005;27(3):425–433.
- Kottmaier M, et al. Quality of Life and Anxiety in Younger Patients after Biological versus Mechanical Aortic Valve Replacement. Thorac Cardiovasc Surg. 2017;65(3):198–205.
- Johnston DR, et al. Intermediate-term outcomes of aortic valve replacement using a bioprosthesiswith a novel tissue. J ThoracCardiovasc Surg. 2020. 5. Bartus K, et al., Five-year Outcomes of Aortic Valve Replacement Using a Bioprosthetic Valve with the Novel RESILIA Tissue: Final Study Results. Structural Heart, 2019; vol3, no.S1, 18.
- Bartus K, et al., Five-year Outcomes of Aortic Valve Replacement Using a Bioprosthetic Valve with the Novel RESILIA Tissue: Final Study Results. Structural Heart, 2019; vol3, no.S1, 18
Important safety information
INSPIRIS RESILIA aortic valve
Indications: For use in replacement of native or prosthetic aortic heart valves.
Contraindications: There are no known contraindications with the use of the INSPIRIS RESILIA aortic 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, any of which could lead to reoperation, explantation, permanent disability, and death.
Warnings: DO NOT ADJUST THE VALVE DIAMETER BY EXPANDING THE BAND PRIOR TO/OR DURING IMPLANTATION OF THE SURGICAL VALVE. The expandable band is not designed to allow for compression or expansion during implantation of the surgical valve. This will cause damage to the valve and may result in aortic incompetence. DO NOT PERFORM STAND-ALONE BALLOON AORTIC VALVULOPLASTY PROCEDURES ON THIS VALVE FOR THE SIZES 19 – 25 mm as this may expand the valve causing aortic incompetence, coronary embolism or annular rupture. Valve-in-valve sizing in the INSPIRIS valve has only been tested with specific Edwards transcatheter heart valves. Use of other transcatheter valves may result in embolization of transcatheter devices anchored within or result in annular rupture.
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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