The SAPIEN 3 Ultra Valve,
Powered by RESILIA Tissue

The SAPIEN 3 Ultra Valve,
Powered by RESILIA Tissue

Building on the benefits of the SAPIEN 3 platform with RESILIA tissue's calcium-blocking technology*2

Calcification is a leading cause of structural valve deterioration (SVD) in aortic tissue valves.1 RESILIA tissue effectively addresses calcification with advanced calcium-blocking.*2

Stable capping blocks calcium from binding to tissue*2

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

See the difference

RESILIA tissue reduced calcification, when compared to traditional surgical valve tissue treatment.

RESILIA tissue features the same tissue technology used in the #1 implanted surgical valve globally

Delivering the potential to improve valve longevity and reduce reintervention*†

*No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.
†RESILIA tissue tested against tissue from commercially available bovine pericardial valves from Edwards in a juvenile sheep model. Flameng, et al. J Thorac Cardiovasc Surg 2015;149:340-5.

The only transcatheter heart valve (THV) with dry tissue storage

SAPIEN 3 Ultra valve's taller* paravalvular leak (PVL) skirt available in four sizes

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

*Compared to SAPIEN 3 valve

The SAPIEN 3 transcatheter heart valve platform addresses the vital considerations for lifetime management

†In the PARTNER 3 trial, SAPIEN 3 TAVI was proven superior to surgery on the primary endpoint of all-cause death, all stroke, and reshospitilization (valve-related or procedure-related, and including due to heart failure) at one year and multiple prespecified secondary endpoints in low risk patients.

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

In a robust clinical trial, surgical valves with RESILIA tissue demonstrated 99.3% freedom from structural valve deterioration (SVD) at 7 years.*3

99.3%

freedom from SVD at 7 years*

85.4%

freedom from all cause mortality at 7 years

*SVD was adjudicated per Akins et al 2008.

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References:   1. Schoen F, et al. Calcification of Tissue Heart Valve Substitutes: Progress Towards Understanding and Prevention. Ann Thorac Surgery 2005 79;1072-80 2. Flameng W, Hermans H, Verbeken E, et al: Randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015;149(1):340-345. 3. Beaver T, Bavaria JE, Griffith B, et al. Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis. Presented at the 103rd Annual Meeting of the American Association for Thoracic Surgery, May 2023. 4. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. NEJM. 2019; 380:1695-1705. doi:10.1056/NEJMoa1814052. 5. Nazif TM, Cahill TJ, Daniels D, et al. Real-world experience with the SAPIEN 3 Ultra transcatheter heart valve: a propensity-matched analysis from the United States. Circ Cardiovasc Interv. 2021;14:e010543. doi:10.1161/ CIRCINTERVENTIONS.121.010543. 6. Tarantini G, Nai Fovino L, Le Prince P, et al. Coronary access and percutaneous coronary intervention up to 3 years after transcatheter aortic valve implantation with a balloon-expandable valve. Circ Cardiovasc Interv. 2020;13:e008972. doi:10.1161/CIRCINTERVENTIONS.120.008972.