Page 8 - Edwards SAPIEN 3 Ultra Implanter Brochure

Experience the difference with the SAPIEN 3 Ultra valve
Learn more at SAPIEN3Ultra.com.
References:
1. The PARTNER II Trial intermediate-risk cohort 30-day unadjusted clinical event rates for TAVR with the SAPIEN 3 valve,
AT population (n=1077).
2. Webb, John. A prospective multicenter study of the SAPIEN 3 Ultra system in intermediate-risk patients with severe aortic stenosis. Presented at: PCR London Valves 2019; November 2019; London, UK.
3. Tarantini G, Fovino LN, Leprince P, et al. Predictors, feasibility and outcomes of coronary intervention up to 3 years after TAVI with a balloon-expandable valve: results from a large European multicenter registry. Presented at: ESC Congress 2019; September 2019; Paris, France.
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, Axela, Commander, Edwards Commander, Edwards eSheath, eSheath, PARTNER II, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
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