aorfix fda approval eu
DESCRIPTION
aorfix approval fdaTRANSCRIPT
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
www.lombardmedical.com
The only AAA stent graft licenced to treat all angulations from 0° to 90°
Now FDA approved
Unrivalled performance in high angulations that speaks for itself.
EVAR related outcomes2 <60°, N=67 ≥60°, N=143
Type Ia/III Endoleak 0% 1.9%
Sac Expansion > 5mm 0% 1.8%
Migration > 10mm 0% 1.7%
Comparison of IFU indications for neck angulations
0°– 60° 60°– 90°
AAA stent graft EU US EU US
Aorfix™
Endurant1
Zenith1
Excluder1