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The INSPIRIS RESILIA aortic valve

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The INSPIRIS RESILIA aortic valve: right for today, ready for tomorrow

With its enhanced anti-calcification procedure and VFit technology, the INSPIRIS RESILIA aortic valve has the potential to offer your patients a longer-lasting valve that does not limit their future treatment options.1

The first valve choice dictates the lifetime management of aortic valve disease.2 Mechanical valves offer durability but the continuous anticoagulation with warfarin complicates management and is associated with severe risk of bleeding.3,4 As a result, patients are increasingly turning to tissue valves.3,5 With life expectancy on the rise,6 patients need longer lasting valves that also won’t limit their future treatment options.

The INSPIRIS RESILIA aortic valve provides a confident foundation for your patients’ future

Enhanced anti-calcification technology1,7–11

RESILIA tissue is bovine pericardial tissue treated with a special integrity preservation technology that mitigates free aldehydes,  potentially allowing the valve to last longer.*1,7–11

In other glutaraldehyde-fixed tissues, the treatment chemicals are able to diffuse out of the tissue over time. This means those tissues become increasingly susceptible to calcification.11,12

The INSPIRIS RESILIA aortic valve is made of RESILIA tissue which undergoes a proprietary process that mitigates free aldehydes.1,7–9

1 / 3
glutaraldehyde saturation
Integrity preservation technology - 1
Integrity preservation technology - 2
glutaraldehyde saturation
Integrity preservation technology - 1
Integrity preservation technology - 2

*Based on bench data.

RESILIA tissue offers enhanced anti-calcification properties.1,7–12

VFit technology: designed to enable potential future valve-in-valve procedures

Irrespective of the choice of bioprosthesis, some patients will require a second intervention. The INSPIRIS RESILIA aortic valve has been designed to enable flexibility of future treatment options for both surgeons and patients.1

Other tissue valves may require valve fracture as part of a valve-in-valve (ViV) procedure, but it has been associated with higher odds of in-hospital mortality (odds ratio 2.51, P<0.01) and life-threatening bleeding (odds ratio 2.55, P<0.01).13 Unlike other valves, the INSPIRIS RESILIA aortic valve is specifically designed to deliver a controlled and predictable expansion during potential future ViV deployment.†14–16


VFit technology incorporates two novel features designed for potential future ViV procedures:‡1

vfit details

†Based on bench data.
‡Refer to device instructions 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 ViV procedures. VFit technology is available on sizes 19–25 mm.1

VFit technology safety instructions for future intervention1

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.

VFit Expansion

WARNING: Valve-in-valve sizing in the INSPIRIS RESILIA aortic 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.

Consider the INSPIRIS RESILIA aortic valve for your next SAVR patient

INSPIRIS RESILIA - Patients thumb

Choosing an aortic valve that does not compromise your patient’s quality of life or future treatment approaches is crucial

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Find out about the clinical evidence behind the INSPIRIS RESILIA aortic valve. 

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INSPIRIS RESILIA - Helpful resources thumb

Visit our resources section for additional information on aortic valve disease and the INSPIRIS RESILIA aortic valve.

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Abbreviations

SAVR, surgical aortic valve replacement; ViV, valve-in-valve.

References

  1. Edwards Lifesciences. INSPIRIS RESILIA Aortic Valve, Model 11500A, Instructions for use. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150048D.pdf. Accessed December 2023.
  2. Basman C, et al. J Cardiol. 2022;80(3):185–9.
  3. Schnittman SR, et al. J Thorac Cardiovasc Surg. 2018;155:539–47.
  4. Ruel M, et al. Eur J Cardiothorac Surg. 2005;27(3):425–33.
  5. Brown JM, et al. J Thorac Cardiovasc Surg. 2009;137:82–90.
  6. WHO. GHE: Life expectancy and healthy life expectancy. Available at: https://www.who.int/data/gho/data/themes/mortality-and-global-health-estimates/ghe-life-expectancy-and-healthy-life-expectancy. Accessed December 2023.
  7. Flameng W, et al. J Thorac Cardiovasc Surg. 2015;149:340–5.
  8. De la Fuente AB, et al. J Heart Valve Dis. 2015;24(1):101-9.
  9. Tod TJ, et al. J Mater Sci Mater Med. 2016;27(1):8.
  10. Beaver T, et al. J Thorac Cardiovasc Surg. 2023;S0022-5223(23)00873–5.
  11. Edwards Lifesciences. Capping bioprosthetic tissue to reduce calcification. European Patent 13003386.3. 2013.10.09.
  12. Velho TR, et al. Braz J Cardiovasc Surg. 2022;37(2):239–50.
  13. Garcia S, et al. Presented at Transcatheter Cardiovascular Therapeutics congress, 2022.
  14. Edwards Lifesciences. Data on File. S-9952.
  15. Saxon JT, et al. Interv Cardiol. 2018;13(1):20–6.
  16. Barbanti M, et al. Circulation. 2013;128:244–53.

No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients. Additional clinical data for up to 10 years of follow-up are being collected to monitor the long-term safety and performance of RESILIA tissue. 

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. VFit technology is available on sizes 19–25 mm.

Medical device for professional use

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).