aorfix fda approval eu

1
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 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% Comparison of IFU indications for neck angulations 0°– 60° 60°– 90° AAA stent graft EU US EU US Aorfix™ Endurant 1 Zenith 1 Excluder 1

Upload: salutaria

Post on 19-Mar-2016

215 views

Category:

Documents


1 download

DESCRIPTION

aorfix approval fda

TRANSCRIPT

Page 1: Aorfix FDA approval EU

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