Page 20 - Edwards Higher Standard Brochure PP--US-5551 v3.0
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Welcome to the Higher Standard.
Your standard.
1. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380:1695-1705.
2. PARTNER II Trial intermediate-risk cohort 30-day unadjusted clinical event rates for TAVR with the SAPIEN 3 valve, AT population (n=1077).
3. Mack MJ. Two-year clinical and echocardiographic outcomes from the PARTNER 3 low-risk randomized trial. Presented at ACC 2020; March 2020; Virtual meeting.
4. Nazif T, Daniels D, McCabe J, et al. Real-world experience with the SAPIEN 3 Ultra TAVR: A propensity matched analysis from the United States. Presented at: TVT Connect 2020; June 2020; Virtual meeting.
5. Data on file, analysis of 2018 Medicare SAF files.
6. Wood, DA, Lauck SB, Cairns JA, et al. The Vancouver 3M (multidisciplinary, multimodality, but minimalist) clinical pathway facilitates safe next-day discharge home at low-, medium-, and
high-volume transfemoral transcatheter aortic valve replacement centers: the 3M TAVI study. JACC Cardiovasc Interv. 2019;12(5):459-469.
7. Kodali S, et al. SAPIEN 3 transcatheter aortic valve replacement compared with surgery in intermediate-risk patients: a propensity matched analysis of 5 year outcomes. Presented at:
TVT Connect 2020; June 21, 2020; Virtual meeting.
8. 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(7):e008972.
9. The PARTNER 3 Trial, low-risk bicuspid registry, N=71. Edwards Lifesciences data on file.
See enclosed Important Safety Information.
CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician. SAPIEN 3 and SAPIEN 3 Ultra involve serious risks, including death, stroke, major bleeding, and major vascular complications.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards Commander, PARTNER II, PARTNER 3, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
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