INSPIRIS RESILIA Aortic Valve
Right for today.
Ready for tomorrow.
The right choice today.
Because today, your patients want an improved quality of life and the potential to expand their future options.
Feel confident with a design and features you can trust.
The INSPIRIS RESILIA aortic valve incorporates features of the trusted Edwards PERIMOUNT and Magna Ease aortic valve platforms to enhance ease of implant.1,2,3
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.4,5
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
Built with RESILIA tissue†, the INSPIRIS valve is designed to oﬀer enhanced tissue anti-calciﬁcation technology that will potentially allow the valve to last longer.6
- RESILIA tissue is bovine pericardial tissue treated with a special integrity preservation technology that effectively eliminates free aldehydes, a key factor in tissue calcification, while protecting and preserving tissue.6,7
- RESILIA tissue is the result of a development program of over 10 years, involving more than 100 evaluations of safety and efficacy.
Backed by a strong and growing base of preclinical and clinical evidence supporting its ongoing study of durability and hemodynamic performance.6,8,9
Ready for tomorrow.
Help your patients meet the future confidently, with enhanced options for subsequent valve intervention.
The INSPIRIS RESILIA 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.
Unlike other valves, the INSPIRIS RESILIA valve is specifically designed to deliver a controlled and predictable expansion during valve-in-valve deployment.*10
How VFit technology enables controlled expansion
INSPIRIS RESILIA Aortic Valve
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
FOR MODEL 11500A SIZES 19–25 MM ONLY.
WARNING: DO NOT PERFORM STAND-ALONE BALLOON AORTIC VALVULOPLASTY PROCEDURES ON THIS VALVE FOR THE SIZES 19 – 25 mm. Although the valve will maintain a stable diameter at implant and during intracardiac conditions, the diameter of this valve will expand if radial force is applied, such as during a balloon aortic valvuloplasty. This may expand the valve causing aortic incompetence, coronary embolism or annular rupture.
The expansion zone is activated by applied radial force. Click video below to view the band expansion.
WARNING: 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. Refer to device instructions for use for full prescribing and safety information.
Intended use and indications for use
The INSPIRIS RESILIA Aortic Valve, Model 11500A, is intended for use as a heart valve replacement.
The INSPIRIS RESILIA Aortic Valve, Model 11500A, is indicated for the replacement of native or prosthetic aortic heart valves.
- Valve leaflets: Bovine pericardium
- Stent: Cobalt-chromium alloy, polyester
- Fabric covering stent: Polyester cloth
- Valve sewing ring: Silicone rubber
Model 11500A features RESILIA tissue, bovine pericardial tissue transformed by a novel integrity preservation technology, which incorporates two new proprietary features that, effectively eliminate free aldehydes while protecting and preserving the tissue.
General Product Information
- Storage temperature: 10°C to 25°C
- Storage: Dry storage
- Rinse procedure: None required, ready for use
- VFit technology: Expansion zone and fluoroscopically visible size marker on sizes 19-25mm¥
|11500A||INSPIRIS RESILIA aortic valve||19, 21, 23, 25, 27 & 29 mm|
|1133SET||Sizers – Complete Set||19, 21, 23, 25, 27, and 29 mm|
|1133||Sizers - Individual||19, 21, 23, 25, 27, and 29 mm|
|1126||Longer Single-Use Handle||N/A|
The Edwards Advantage
We are committed to providing your institution, clinicians and staff with the highest levels of customer service and support to ensure seamless product implementation and ongoing use, including:
- 24/7 technical support – Simply call 800-822-9837 or email email@example.com anytime, day or night
- Customer service – Call 800-424-3278 to speak to a customer service representative
Contact a sales representative
- Johnston DR, et al. Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants. Ann Thorac Surg. 2015;99:1239—47.
- Forcillo J, et al. Carpentier-Edwards pericardial valve in the aortic position: 25-years experience. Ann Thorac Surg. 2013;96:486—93.
- Bourguignon T, et al. Very long-term outcomes of the Carpentier-Edwards PERIMOUNT valve in aortic position. Ann Thorac Surg. 2015;99:831—7.
- 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.
- Flameng W, et al. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015; 149:340–5.
- Priev A, et al. Glycerol decreases the volume and compressibility of protein interior. Biochemistry. 1996;35(7):2061‐2066.
- Bavaria, J.E. et al., Five-year outcomes of the COMMENCE trial investigating aortic valve replacement with a novel tissue bioprosthesis. The society of Thoratic Surgeon, 2021 Annual Meeting.
- 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
- Saxon JT, et al. Bioprosthetic Valve Fracture During Valve-in-valve TAVR: Bench to Bedside. Interv Cardiol. 2018;13(1):20‐26.
- Saxon JT, et al. Complications of Bioprosthetic Valve Fracture as an Adjunct to Valve-in-Valve TAVR, Structural Heart, 2019;3:2, 92-99.
The INSPIRIS RESILIA valve is from Edward Lifesciences, the company trusted by surgeons for more than 60 years to deliver safe, responsible structural heart disease innovation.
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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