The SAPIEN 3 Ultra RESILIA valve

Effectively addressing calcification, a leading cause of tissue valve failure.*2

*No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.

Taller, textured skirt technology to reduce PVL*5

Scroll / swipe side to side to review valve line-up

*Compared to SAPIEN 3 valve
PVL = Paravalvular Leak

RESILIA tissue reduced calcification when compared to traditional surgical valve tissue treatment*

Delivering the potential to improve valve longevity and reduce reintervention

RESILIA tissue showed significant improvement in calcium-blocking properties*

*RESILIA tissue tested against tissue from commercially available bovine pericardial valves from Edwards Lifesciences in a juvenile sheep model.

RESILIA tissue showed excellent and consistent outcomes over 7 years7

RESILIA tissue data from the COMMENCE aortic trial* show:

99.3%

Freedom from SVD at 7 years*

97.2%

Freedom from re-operation at 7 years*

85.4%

Freedom from all-cause mortality at 7 years

*Includes the following valve sizes: 19 mm, 21 mm, 23 mm, 25 mm, 27 mm, 29 mm.
†*SVD: Structural Valve Deterioration defined as dysfunction or deterioration involving the operated valve (exclusive of infection or thrombosis), as determined by reoperation, autopsy or clinical investigation with periodic echocardiography; SVD refers to valve intrinsic changes, such as wear and tear, fracture, calcification, etc. (Akins et al, 2008). SVD was adjudicated by independent committee.

RESILIA tissue is a transformative calcium-blocking technology*3

RESILIA tissue is the product of nearly 20 years of research and development and used in the INSPIRIS valve, the #1 implanted surgical valve in the US. RESILIA tissue is a proprietary stable capping technology targeting free aldehydes to prevent calcification: the primary driver of structural valve deterioration (SVD) for aortic tissue valves.*3

*No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.

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SAPIEN 3 Ultra RESILIA Brochure
Find out more about SAPIEN 3 Ultra RESILIA valve.

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TVT-R Clinical Data
Learn more about SAPIEN 3 Ultra RESILIA valve from real world registry.

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Real-World Outcomes for the SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve
A summary of the results, patient demographics, study methods, and key outcomes

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SAPIEN 3 Ultra RESILIA Clinical Data One Pager
See the Clinical Evidence Behind RESILIA Tissue

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References:   1. Data on file. 2. De la Fuente et al. Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and Safety. Journal of Heart Valve Disease. 2015. 3. Kodali S et al. Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards SAPIEN valve in the PARTNER trial: characterizing patients and impact on outcomes. Eur Heart J. 2015. 4. Makkar R et al. Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement. N Engl J Med. 2020. 5. Stinis CT, Abbas AE, Teirstein P, et al. Real-World Outcomes for the Fifth-Generation Balloon Expandable Transcatheter Heart Valve in the United States. JACC Cardiovasc Interv. 2024. 6. Flameng W, Hermans H, Verbeken E, et al. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015. 7. Beaver T, Bavaria J, Griffith B, et al. Seven-Year Outcomes Following Aortic Valve Replacement with a Novel Tissue Bioprosthesis. Journal of Thoracic and Cardiovascular Surgery. 2023.

No clinical data are available to 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).