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CoreValve™ Evolut™ R


Catalog excerpts

CoreValve™ Evolut™ R - 1

LIFE IS DIFFERENT CoreValve™ Evolut™ R Transcatheter Aortic Valve Replacement (TAVR) Platfor

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CoreValve™ Evolut™ R - 2

BUILT ON A PROVEN FOUNDATION The CoreValve™ System continues to demonstrate exceptional outcomes — and we’ve taken what we’ve learned from the design of that platform and applied it to the Evolut™ R System. Supra-annular Valve Design Self-expanding Nitinol Frame Porcine Pericardial Tissue Low Delivery

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CoreValve™ Evolut™ R - 3

SUPERIOR LONG-TERM CLINICAL OUTCOMES Lower Rate of Mortality or Stroke Unsurpassed Sustained Hemodynamic Performance All-Cause Mortality or Stroke Echocardiographic Findings* Log-rank P=0.006 CoreValve SAVR CoreValve SAVR The CoreValve™ Platform shows superior outcomes vs. surgery.1 1. CoreValve™ US Pivitol High Risk Trial 3-year Outcomes Presented at ACC 2016. No. at Risk 391 TAVR SAVR 359 All-Cause Mortality or Stroke (%) CoreValve™ system had significantly better valve performance over SAVR at all follow-up visits (P<0.00

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CoreValve™ Evolut™ R - 4

UNSURPASSED HEMODYNAMICS Supra-annular valve design maximizes leaflet coaptation and promotes single digit gradients and large EOA’s. 7.5 mm Hg single digit gradients Evolut™ R 30 Day Outcomes. CoreValve™ Evolut™ R System Instructions for Use 2016 Rev

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CoreValve™ Evolut™ R - 5

Supra-annular Valve | Optimizes coaptation in non-circular anatomy with supra-annular valve position Annulus | Conforms to the native annulus Exceptional Survival

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CoreValve™ Evolut™ R - 6

CONTROL DURING DEPLOYMENT ACCURATE POSITIONING 1:1 response provides immediate feedback between the deployment knob and the movement of the capsule RECAPTURE AND REPOSITION EnVeo™ R provides option to recapture and reposition for accurate placement. Tactile Indicator ~ 2/3 Deployment Just Prior to Point of No Recapture†

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CoreValve™ Evolut™ R - 7

ACCESS MORE PATIENTS BROADEST ANNULUS RANGE ON THE MARKET** The only TAVR platform indicated to treat annulus up to 30 mm LOWEST DELIVERY PROFILE The only TAVR system with a vessel indication down to 5.0 mm*** Broadest annulus range based on CT derived diameters Measurement for TAV-in-SAV only. Evolut™ R 23, 26 and 29 mm valves. 34 mm valve minimum vessel indication ≥ 5.5 mm

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CoreValve™ Evolut™ R - 8

INDICATIONS The Medtronic CoreValve and CoreValve Evolut R systems are indicated for use in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (ie, Society of Thoracic Surgeons predicted risk of operative mortality score ≥8% or at a ≥15% risk of mortality at 30 days). CONTRAINDICATIONS The CoreValve and CoreValve Evolut R systems are...

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