INSPIRIS RESILIA Aortic Valve

Right for today.
Ready for tomorrow.

Women running on beach

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 valve platform 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.8,9

INSPIRIS valve

Backed by a strong and growing base of preclinical and clinical evidence supporting its ongoing study of durability and hemodynamic performance.6,8,9

No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.
COMMENCE clinical trial
European feasibility trial
COMMENCE clinical trial
European feasibility trial

Father and son playing basketball

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

*Based on bench data. Refer to device Instructions for Use for important warnings related to VFit technology. These features have not been observed in clinical studies to establish the safety and effectiveness of the model 11500A for use in valve-in-valve procedures.

How VFit technology enables controlled expansion

Predictable expansion with a controllable wireframe
Valve expansion is activated by the radial force applied by the dilation of the new transcatheter valve within the existing INSPIRIS RESILIA valve, resulting in a uniform and controlled expansion around the INSPIRIS RESILIA valve's perimeter.
A perforated polyester band is designed to separate at each of the 3 commissures during deployment of the new transcatheter valve, delivering controlled, predictable and uniform expansion of the valve's internal orifice.
VFit technology is available on sizes 19-25mm for a broad range of patients with varying annulus size.
Predictable expansion with a controllable wireframe
Valve expansion is activated by the radial force applied by the dilation of the new transcatheter valve within the existing INSPIRIS RESILIA valve, resulting in a uniform and controlled expansion around the INSPIRIS RESILIA valve's perimeter.
A perforated polyester band is designed to separate at each of the 3 commissures during deployment of the new transcatheter valve, delivering controlled, predictable and uniform expansion of the valve's internal orifice.
VFit technology is available on sizes 19-25mm for a broad range of patients with varying annulus size.
*Refer to device Instructions for Use for important warnings related to VFit technology. These features have not been observed in clinical studies to establish the safety and effectiveness of the model 11500A for use in valve-in-valve procedures.

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

COMMENCE Trial Clinical Summary

The COMMENCE trial: Four-year outcomes with an aortic bioprosthesis with RESILIA tissue

Download brochure

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.

*VFit technology has not been observed in clinical studies to establish the safety and effectiveness of the model 11500A for use in valve-in-valve procedures.

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.

Materials List

  • Valve leaflets: Bovine pericardium
  • Stent: Cobalt-chromium alloy, polyester
  • Fabric covering stent: Polyester cloth
  • Valve sewing ring: Silicone rubber

Tissue Platform

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 on sizes 19-25mm¥
¥ Refer to device Instructions for Use for important warnings related to VFit technology. These features have not been observed in clinical studies to establish the safety and effectiveness of the model 11500A for use in valve-in-valve procedures.
ModelDescriptionSizesImage
11500A INSPIRIS RESILIA aortic valve 19, 21, 23, 25, 27 & 29 mm INSPIRIS RESILIA aortic valve
ModelDescriptionSizes
1133SET Sizers – Complete Set 19, 21, 23, 25, 27, and 29 mm
1133 Sizers - Individual 19, 21, 23, 25, 27, and 29 mm
TRAY1133 Accessory Tray N/A
1111 Reusable Handle N/A
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 tech_support@edwards.com anytime, day or night
  • Customer service – Call 800-424-3278 to speak to a customer service representative

Contact a sales representative

References

  1. Johnston DR, et al. Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants. Ann Thorac Surg. 2015;99:1239—47.
  2. Forcillo J, et al. Carpentier-Edwards pericardial valve in the aortic position: 25-years experience. Ann Thorac Surg. 2013;96:486—93.
  3. Bourguignon T, et al. Very long-term outcomes of the Carpentier-Edwards PERIMOUNT valve in aortic position. Ann Thorac Surg. 2015;99:831—7.
  4. 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.
  5. 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.
  6. 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.
  7. Priev A, et al. Glycerol decreases the volume and compressibility of protein interior. Biochemistry. 1996;35(7):2061‐2066.
  8. Johnston DR, et al. Intermediate-term outcomes of aortic valve replacement using a bioprosthesis with a novel tissue. J Thorac Cardiovasc Surg. 2020.
  9. 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
  10. Saxon JT, et al. Bioprosthetic Valve Fracture During Valve-in-valve TAVR: Bench to Bedside. Interv Cardiol. 2018;13(1):20‐26.
  11. 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

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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