Aorfix FDA approval EU

Page 1

The only AAA stent graft licenced to treat all angulations from 0° to 90° Now FDA approved Comparison of IFU indications for neck angulations AAA stent graft

0°– 60° EU

US

60°– 90° EU

US

Aorfix™ Endurant1 Zenith1 Excluder1

Unrivalled performance in high angulations that speaks for itself. EVAR related outcomes 2

<60°, N=67

≥60°, N=143

Type Ia/III Endoleak

0%

1.9%

Sac Expansion > 5mm

0%

1.8%

Migration > 10mm

0%

1.7%

www.lombardmedical.com 1. Refer to individual product IFUs for full indications; 2. Aorfix™ US IDE trial results, see Aorfix™ AAA Flexible Stent Graft IFU for full details.

PN01845A


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