*Study only included the use of SAPIEN 3 valve.

Up to 75% of severe aortic stenosis patients undergoing TAVI have CAD* requiring future coronary intervention.5

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Durability that stands up to SAVR through 5 years

Low rates of SVD and SVD-related BVF at 5 years in the PARTNER II trial4

*Stage 2 & 3 (moderate & severe HVD): morphological valve deterioration AND +Δ mean gradient ≥ 10 mmHg with final mean gradient ≥ 20 mmHG§ and any of: -Δ AVA ≥ 0.3 cm2 (or ≥ 25%)§, -Δ DVI ≥ 0.1 (or ≥ 20%)§ OR ≥ 1 grade Δ transvalvular AR with final grade ≥ moderate.

Stage 3 (severe HVD): morphological valve deterioration AND +Δ mean gradient ≥ 20 mmHG with final mean gradient ≥ 30 mmHg§ and any of: -Δ AVA ≥ 0.6 cm2 (or ≥ 50%)§, -Δ ≥ 0.2 (or ≥ 40%)§ OR ≥ 2 grade Δ transvalvular AR with severe final grade.

In this study, we used PARTNER II propensity matched data to analyze SVD rates, there was no statistically significant difference between SAPIEN 3 TAVI and SAVR for all endpoints except for all-cause BVF. The majority of cases within all-cause BVF in SAVR were due to endocarditis, while in TAVI they were due to paravalvular AR, a form of nonstructural valve dysfunction.

§Compared to echocardiographic assessment performed 1 to 3 months post-procedure (or discharge if not available).

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The SAPIEN 3 valve shows excellent outcomes in low-risk bicuspid patients9

PARTNER 3 trial low-risk bicuspid nested registry

No moderate or severe PVL at 1 year9

Real world SAPIEN 3 TAVI in 3,100+ bicuspid patients: No difference in mortality or stroke at 1 year compared to tricuspid patients10

Paravalvular regurgitation

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SAPIEN 3 Ultra is approved for THV-in-THV and mitral valve-in-valve.

Treatment options with SAPIEN 3 TAVI

Aortic ViV
Aortic THV-in-THV
Mitral ViV

References:   1. Ochiai T, Chakravarty T, Yoon SH, et al. Coronary access after TAVR. JACC Cardiovasc Interv. 2020;13(6):693-705. 2. De Backer O, Landes U, Fuchs A, et al. Coronary access after TAVR-in-TAVR as evaluated by multidetector computed tomography. JACC Cardiovasc Interv. 2020; 13(21):2528-2538. 3. 2017 ACS Census Data, 2018 Medicare Quarterly SAF. 4. Pibarot, et al. Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in PARTNER II Trial. J Am Coll Cardiol. 2020. 5. Yudi MB, Sharma SK, Tang GHL, Kini A. Coronary angiography and percutaneous coronary intervention after transcatheter aortic valve replacement. J Am Coll Cardiol. 2018;71(12):1360-1378. 6. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expendable valve in low-risk patients. N Engl J Med. 2019;380(18):1695-1705. 7. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374(17):1609-1620. 8. Leon MB, Smith CR, Mack MJ, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597-1607. 9. Williams M.et al. The PARTNER 3 Bicuspid Registry for SAPIEN 3 TAVR in Low Surgical Risk Patients; Presented at TCT 2020; October 202, tctconnect.com. 10. Makkar RR, et al. Outcomes of Transcatheter Aortic Valve Replacement for Bicuspid Aortic Valve Stenosis in the Low-Surgical Risk Population. EuroPCR 2021 May. 11. Tarantini G, Fovino LN, 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.