The INSPIRIS RESILIA aortic valve

Patients affected by aortic valve disease seek a long-lasting solution that does not limit their future treatment options or impacts their day-to-day life.¹

Valve selection is a lifelong commitment which requires careful consideration of valve durability and the impact it could have on possible secondary interventions.

Recommending the right valve means getting closer to valve therapy and therefore to your patients' needs.

The INSPIRIS RESILIA aortic valve offers your patients a solution that's right for today and ready for tomorrow.

Who could benefit today and tomorrow from the INSPIRIS RESILIA aortic valve?

The INSPIRIS RESILIA aortic valve is suitable for a broad range of patients² while facilitating the lifetime management of their aortic valve disease.

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Phil, 55 years old

Manages his own IT business
Travels regularly because of work
Loves cycling, wherever he might be in the world, as well as sailing
Diagnosed with severe aortic stenosis (AS) after a period of increasing difficulty keeping up with his usual physical activity
Eligible for surgical aortic valve replacement (SAVR)
Keen to get back to doing the things he loves

Anna, 33 years old

Primary school teacher
Diagnosed with bicuspid aortic valve in her late 20s
Graded as having severe AS at her last follow-up appointment
Eligible for SAVR
Recently married and looking to start a family as soon as possible

Maya, 62 years old

Spends most of her time looking after her grandchildren
Diagnosed with type 2 diabetes (T2D) in her early 50s
Current body mass index (BMI) is 32
Despite her best efforts she has been unable to lose weight
Diagnosed with symptomatic severe AS, following a cardiology referral from her endocrinologist
Eligible for SAVR
Small aortic annulus

Mo, 66 years old

Retired security officer
Ex-smoker
As his AS progressed, he had to give up on the weekly game of five a side football with his friends
Eligible for SAVR

The 2021 ESC/EACTS guidelines do not recommend bioprostheses in patients below 60 years of age, however, informed patient preference and lifestyle also plays a critical role in the decision-making process for the choice of prosthetic valve.³

The INSPIRIS RESILIA aortic valve is the market-leading replacement aortic valve⁴

To date, more than 200,000 INSPIRIS RESILIA aortic valves have been implanted into patients worldwide⁵

Help your patients meet the future confidently, with enhanced anti-calcification tissue and VFit technology designed to allow potential future subsequent valve intervention.^{2, 6–10}

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.

Building on a trusted foundation

The INSPIRIS RESILIA aortic valve is the latest generation of aortic tissue valve developed by Edwards Lifesciences, and builds upon the proven Carpentier-Edwards PERIMOUNT Magna Ease aortic valve with additional features.

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*No clinical data are available that evaluate the long-term impact of the Carpentier–Edwards ThermaFix treatment in patients.
†No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients. The INSPIRIS RESILIA valve alloy band represents 19-25mm sizes. The sizes 27 and 29 mm do not have VFit technology.

The INSPIRIS RESILIA aortic valve can be implanted via minimally invasive procedures¹⁷ for faster recovery times.¹⁸
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Right for today, ready for tomorrow.

Explore how the features of the INSPIRIS RESILIA aortic valve might facilitate lifelong management of aortic valve disease.

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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

^{AS, aortic stenosis; BMI, body-mass index; SAVR, surgical aortic valve replacement; T2D, type 2 diabetes.}

References

Lauck SB et al. Can J Cardiol. 2021;37:1054–63.
Edwards Lifesciences. INSPIRIS RESILIA Aortic Valve, Model 11500A, Instructions for use. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150048D.pdf. Accessed March 2024.
Vahanian A, et al. Eur Heart J. 2022;43:561–632.
Edwards Lifesciences. INSPIRIS RESILIA Aortic Valve, Model 11500A, DOF S-20315.
Edwards Lifesciences. INSPIRIS RESILIA Aortic Valve, Model 11500A, DOF-S-20278.
Kottmaier M, et al. Thorac Cardiovasc Surg. 2017;65(3):198–205.
Ruel M, et al. Eur J Cardiothorac Surg. 2005;27(3):425–33.
Beaver T, et al. J Thorac Cardiovasc Surg. 2023;S0022-5223(23)00873–5.
Flameng W, et al. J Thorac Cardiovasc Surg. 2015;149:340–5.
Edwards Lifesciences. Capping bioprosthetic tissue to reduce calcification. European Patent 13003386.3. 2013.10.09.
Edwards Lifesciences. Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX, Instructions for use. Available at: https://eifu.edwards.com/eifu/pages/viewers/pdf?projectKey=5d4dd5ad46e0fb0001c61ac7&itemKey=63b5f608805dc5428c946680. Accessed March 2024.
Edwards Lifesciences. Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprostheses, Model 2800 and Model 2800TFX, Instructions for use. Accessed March 2024.
Ruzicka DJ, et al. Circulation. 2009;120(11 Suppl):S139-45.
De la Fuente AB, et al. J Heart Valve Dis. 2015;24(1):101-9.
Tod TJ, et al. J Mater Sci Mater Med. 2016;27(1):8.
Edwards Lifesciences. INSPIRIS RESILIA Aortic Valve, Model 11500A. DoF S-9952.
Ahmad AE, et al. Adv Ther. 2021;38(5):2435–46.
Glauber M, et al. J Thorac Cardiovasc Surg. 2013;145(5):1222–6.

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.

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).

The INSPIRIS RESILIA aortic valve